DMCG Careers

Want to join our team? Attach your resume, and we will contact you as soon as a position is available. DMCG is constantly working on new client needs. Here are some of the general client role descriptions that DMCG is currently looking to fill. If you are interested please send your MS Word (no PDF) format resume. One of our representatives will contact you as soon as possible.

Resumes to: careers@dmcginc.com

Chemist

Arecibo, PR

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Responsible for performing analytical test to laboratory samples to determine its conformance with established specification. This responsibility includes the testing of materials associated to their area (such as In-Process, Raw Materials, Packaging Components, Stability, Finished Goods and Drug Laboratory samples). Also, is responsible for standardization of solutions and calibration, qualification and validation of sophisticated instruments and methods. Responsible for the safe execution of the assigned tests procedures and proper documentation according to the applicable Quality Standard (QS) procedures and/ or company policies. Knowledgeable of Regulated Laboratory Environment and cGMPs, FDA and DEA guidance. Review analytical and cGMP data and lot releases when required. Coordination of laboratory activities and participate in Tiers when needed. Will ensure Site’s business continuity by providing on-time required Laboratory services.

Education and/ or Experience

List the minimum academic credentials and/or years of experience.
• Bachelor’s Degree in chemistry
• At least one (1) year of laboratory experience.

Licenses and/ or Certifications

Indicate which licenses or professional certifications are required or preferred (Ex. ABC, preferred).
• Puerto Rico Chemist license is required. (Responsible to keep updated)
• Licenses to manage explosive materials, preferred.

PRIMARY RESPONSIBILITIES

Describe briefly the major activities of the position (maximum of 15).
• Working shifts (including weekends).
• Testing of laboratory samples from different sources according to the existing and applicable standards and regulations.
• Troubleshooting of methods and/ or instruments when needed. Carries out special assignment within the area of responsibility such as the development of better test procedures and troubleshooting to make recommendations based on his/her findings.
• Responsible for the interpretation and compliance of QS, procedures, and company policies as well as reviews and evaluates QS, testing guidelines, SOP’s and policies and provides feedback in timely manner.
• Conduct laboratory investigations as part of the non-conforming results reporting. Interpretation and reporting of product laboratory results.
• Prepares and standardizes laboratory solutions for use in laboratory testing. Performs internal verification, as necessary, to laboratory equipment to assure that all results obtained are reliable.
• Document all laboratory records complying with applicable procedures and current Good
• Manufacturing Practices (cGMP’s) as well as DEA regulations.
• Responsible for the Data entry in the various systems such as laboratory instrumentation, LIMS and SAP.
• Qualification and training of peers. Will help to maintain laboratory housekeeping and organized.
• Informs the supervisor of the status of the operation and reports any unusual situation and or problem.
• Handles routine matters independently.
• Reviews the analytical data developed by a first analyst to be in accordance with the acceptance criteria and specifications of procedures.
• Participates in the transfer of new technology and analytical methods to the laboratory.
• Manage, store, handle, dispose, label and inspect laboratory waste following EPA, EQB and site: requirements procedures, guides, and policy. Adheres to all safety requirements in handling toxic and reactive chemicals, testing reagents, glassware, and equipment
• Comply with all environmental trainings, procedures, guidelines, practices, cGMP’s, permit conditions and internal notifications of any environmental event.
• Perform any other job-related duties as required or that may arise in the future.

Technical Competencies

Includes technical, communications, computer, and mathematics competencies (maximum 7).
• Fully bilingual (Spanish and English)
• Knowledge of Good Manufacturing Practices, Good Laboratory Practices, DEA, Safety, EPA and OSHA regulations and rules.
• Knowledge of a wide variety of analytical, chemical and automation disciplines.
• Knowledge and ability to work with computers and computer-based software.
• Able to work under pressure, self-starter and able to handle multiple priorities with minimum supervision.

QA In-Line Technician

Arecibo, PR

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Briefly summarize the primary purpose of the position.
Provide Quality Assurance expertise, support and service for the functional areas and special activities related to Quality. Responsible of assuring that all established controls that support the manufacture of Drug Products quality are implemented and followed. Is accountable for assuring that each production, utilities, facilities, and support areas follows their SOP’s based upon his/her findings and performs the QA verification of the critical control parameters. Plays an active role in identify and resolving Preventive and Corrective Action when needed to avoid potential quality issues. Receives general guidance from the QA Manager or QO Leader but handles routine matters independently. Provides support of compliance and regulatory aspects to other QO Department Areas and Production Personnel.

EDUCATION AND/ OR EXPERIENCE

List the minimum academic credentials and/or years of experience
• Bachelor’s Degree in biology, Chemistry, Microbiology, Industrial Chemical Process or Engineering.
• Minimum 2 years of experience in Pharmaceutical Industry and/ or manufacturing environment or related field.

LICENSES AND/ OR CERTIFICATIONS

Indicate which licenses or professional certifications are required or preferred.
• ASQC Certification as Certified Quality Auditor (CQA), preferred

TECHNICAL COMPETENCIES

Includes technical, communications, computer, and mathematics competencies (maximum 7).
• Fully bilingual (Spanish and English).
• Problem solving abilities, ability to train people and effective oral and written communications skills.
• Computer knowledge.
• Knowledge of Federal Regulations such as cGMP’s, European and as applicable.
• Excellent interpersonal skills.
• Self-starter and good communication skills. Ability to instill confidence.
• Strong understanding of cGMP’s and FDA mandated criteria for product release is essential and other applicable regulation

Laboratory Analyst

Arecibo, PR

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LABORATORY ANALYST

Instrumental chemical and physical analysis of laboratory samples to determine its conformance with established specifications. Standardization of solutions and calibrations, qualification and validation of sophisticated instruments and methods, responsible for the safe execution of the assigned testing procedures and proper documentation according to the applicable QS, procedures and/or company policies. Knowledgeable of Regulated Laboratory Environment and cGMPs, FDA and DEA guidance.

EDUCATION AND/OR EXPERIENCE

List the minimum academic credentials and/or years of experience.
• Bachelor’s degree in science with a Chemistry or Biology majors.
• At least one (1) year of laboratory experience; preferred

LICENSES AND/OR CERTIFICATIONS

Indicate which licenses or professional certifications are required or preferred (Ex. ABC, preferred).
• A license to manage explosive material, preferred
• Chemist Licensed is preferred.

TECHNICAL COMPETENCIES

Includes technical, communications, computer, and mathematics competencies (maximum 7).
• Good oral and written communications skills in English and Spanish (Bilingual).
• Excellent interpersonal skills.
• Knowledge in computers and domain the use of standard computer software applications.
• Understands GMP’s, FDA and DEA regulations, Computer Validation philosophy and method transfer/ validation.
• Knowledge of Good Manufacturing Practice regulations, GLP, EPA regulations, Laboratory Safety Rules, OSHA regulations, classical and modern analytical chemistry or microbiology and sophisticated instrumental techniques.
• Knowledge on HPLC, GC and Dissolution as well as their acquisition system as Empower 3.
• Able to Work under pressure, self -starter and able to handle multiple priorities with minimum supervision.

Project Specialist

North Region of PR – temporary exempt position

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Essential Functions and Scope:
The role is responsible to manage timelines and coordination of Project tasks between the Departments, suppliers and customer. The role will list and organize the execution of the project to assure tasks are completed in a logical sequence that assures that milestone targets are achieved. The role is responsible to prepare project charter, coordinate meetings, keep track of execution, influence removal of roadblocks hindering the project performance, maintan leadership aware of execution against the agreed timeline, serve as a reviewer for project documentation, help in project documentation such as, but not limited to change controls, procedures, among others. The resource could support for a limited time other functions such as C&Q and Technical Operations specialist and perform technical evaluations for the site.

Position Requirements (Education/Experience/Skills/Other):
A bachelor’s degree in Science such as Pharmacy, Engineering, Biotechnology, Chemistry, Physics or Biology.
Minimum of 3 years of experience in a highly-regulated industry like Pharmaceuticals and/or Medical Devices.
Knowledge and proven experience in cGMP environment and in the use of Project Management methodologies.

Accounts Payable

Temporary (5 to 6 months) – North PR Region

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Position Description:
An accounts payable specialist provides both administrative and financial support in a corporate environment by processing accounts payable transactions and monitoring payroll functions in order to make sure that the office operates smoothly, accurately, and effectively.

Essential Duties and Responsibilities of an Accounts Payable Specialist:

•Maintains and monitors the listing of accounts payable and receivable.
•Develops and maintains a filing system for financial information, files, and records.
•Ensures the ready availability of financial documentation.
•Collects and verify invoices, bills, and checks by performing pre-audits to ensure both accuracy and appropriateness prior to payment.
•Corresponds with vendors, maintains updated vendor profiles, and processes vendor checks.
•Tracks expenses, processes expense reports, and prepares analyses of accounts.
•Monitors account balances and related financial activity.
•Data enters invoices and bills to ensure payments
•Issues checks for accounts payable.
•Calculates salaries and distributes paychecks.
•Produces monthly financial report.
Required Knowledge, Skills, and Abilities
•Displays a proficiency in management and data entry.
•Possesses knowledge of general accounting and bookkeeping principles, as well as of any relevant accounting software.
•Is knowledgeable about accounts payable, accounts receivable, and the process of maintaining general ledgers.
•Demonstrates strong communication, analytical, and problem-solving skills.
•Exhibits a strong regard for organizing and prioritizing, as well as an ability to meet deadlines.
•Displays a respect for confidentiality.
•Exhibits strong team building and interpersonal skills.

Education

Bachelor’s degree in accounting, finance, or a related discipline.

Operador de Utilidades

Arecibo, PR

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Requisitos:

•Grado Asociado en electrónica, mecánica industrial, tecnología química, instrumentación, electricidad o licencia de electricista.
•Mínimo tres (3) años de experiencia en el área de utilidades.
•Licencias categoría 1 para plantas de tratamientos de aguas usada y agua potable.
•Debe entender, leer, escribir y hablar el idioma español. También debe leer e interpretar en el idioma inglés.
•Realizar operaciones matemáticas básicas.
•Analizar problemas para conseguir solución a estos.
•Coordinar según prioridades establecidas.
•Bajo la supervisión del Gerente/Coach de Utilidades, el Operador de Utilidades es responsable de la operación de todos los equipos de Utilidades: sistemas HVAC, calderas, “chillers”, compresores de aire, “cooling towers”, sistema eléctrico, planta de tratamiento de agua usadas, sistemas de agua purificada, pozos de agua, sistema de agua potable.
•Puesto temporero no-exento.
Descripción de tareas y responsabilidades esenciales

1.Monitoreo y operación constante de las áreas y equipo relacionado. Estas áreas incluyen: calderas, “chillers”, compresores de aire, sistema de agua caliente, agua purificada, Torres de Enfriamiento estación de agua residuales (PRASA Station/Wastewater Pre-treatment System), Incinerador Termal y Catalítico.
2.Recopilar de forma rutinaria las lecturas de los equipos para establecer un historial de cada uno. Hacer un análisis de tendencias de la lectura tomada y tomar la acción correspondiente para corregir alguna tendencia de ser necesario.
3.Llevar a cabo una evaluación inicial (“troubleshooting”) del sistema, cuando ocurra algún problema técnico o malfuncionamiento del equipo y corregir o llevar el mismo a mantener su operación óptima.
4.Monitorear la estación de PRASA y todos los componentes relacionados dentro de sus funciones normales. Deber cumplir con todas las regulaciones ambientales impuestas en la planta.
5.En el sistema de agua purificada, debe recopilar de forma rutinaria las lecturas de los equipos para establecer un historial de cada equipo relacionado al proceso. Debe asegurarse de que cada lectura está de acuerdo con los parámetros establecidos del sistema y corregir o ajustar el sistema de ser necesario para llevarlo a parámetros.
6.Tomara muestras del sistema de agua purificada con la frecuencia establecida.
7.Será responsable por la operación del área de la Planta de Tratamiento de aguas usadas. Debe monitorearse constantemente a la planta de tratamiento y alertar a su supervisor y al grupo de EHS de haber algún problema con la planta de tratamiento, sus componentes y/o su funcionalidad.
8.El operador de utilidades es responsable de las condiciones ambientales dentro del área de Producción y otras áreas críticas mediante el monitoreo constante de los sistemas de “Building Automation”. Para mantener las condiciones ambientales dentro de cada área, debe monitorear las alarmas y tomar acciones correctivas para remover cualquier alarma que se active. Investigar las causas cuando los parámetros están fuera de sus límites y generar las órdenes de trabajo necesarias para corregir la situación. Llevar a cabo “troubleshooting” cuando el sistema falla.
9.Debe mantener una comunicación abierta con los módulos y suplir los reportes a las áreas afectadas cuan las condiciones estén fuera de sus límites.
10.El operador de utilidades es responsable por la operación de las unidades de “HVAC” localizadas en el “Mezzanine” y el cuarto Mecánico del Módulo A y todos los sistemas relacionados (“reheat coils”, controladores etc). Debe llevar a cabo una inspección visual rutinaria de todos los”AHU’s” asegurándose de que estén operando apropiadamente y que las mismas se mantengan en buen estado tanto físico como operacional.
11.Responsable de mantener todas las áreas de utilidades libres de escombros limpiando las áreas diariamente.
12.Cumplir con todos los entrenamientos, procedimientos, directrices, practicas, buenas practica de manufactura (cGMP’s), condiciones de los permisos ambientales y notificaciones internas de cualquier evento ambiental.
13.Ejercer otras funciones relacionadas con trabajo, según se requiere o que puedan surgir en el futuro.

Data Analyst

Yauco, PR

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Summary:
Manufacturing efficiency and cost can be improved based on the level of scrap, rework and downtime.
It is required to analyze data in order to establish accurate figures.
The Data Analyst will support the data collection and analysis related to scrap, rework and downtime.

Essential Duties, Responsibilities and Qualifications:
Supports Engineering and Manufacturing departments in the following activities:
– Access databases, download & gather scrap, rework and downtime data from various manufacturing lines.
– Quantify production scrap and downtime.
– Works with engineers, supervisors and operations teams to effectively measure, interpret patterns, trends and turn data into useful information to drive business decisions.
– Assists in the creation of scrap & downtime metrics, reporting and improvement targets for different Business Units.
– Prepare reports and technical documentation.
– Communicate effectively thru all department levels (engineering, manufacturing, finance, management) in a professional and respectful way.

Education / Experience:
– Bachelor’s Degree in Science (technical field) or Business Administration
– Skilled and experienced in SAP and Excel is required.
– Knowledge and understanding of scrap, downtime and OEE indicators.
– Knowledge in basic statistics.
– Experience in a manufacturing environment and computer systems.

Other Skills and Abilities:
– Analytical, problem-solving, and critical-thinking skills.
– Excellent interpersonal, technological, written/verbal communication and relation skills in English and Spanish required.
– Ability to create presentations.

Physical Demands and Work Environment:
– While performing the duties of this job, the employee is regularly required to be seated.
– Room temperatures and lighting as found in a typical office environment.
– The noise level in the work environment is usually low/moderate.
– Must be comfortable in an enclosed Clean Room environment.
– This environment could require the use of gown and face masks.

Sr Specialist QA – (29818)
Juncos, PR

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Doctorate degree Science/Engineering and 2 years of directly related experience or Master’s degree in Sciences/Engineering and 6 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 8 years of directly related experience.
Project management and equipment qualification.

Description:

In support of Client’s Quality Assurance program acts as the technical specialist. Review and approve product MP’s.
Approve process validation protocols and reports for mfg. Processes. Represent Quality on incident triage team.
Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents.
Represent QA on NPI team. Lead investigations. Own site quality program procedures. Designee for QA manager on local CCRB.
Doctorate degree and 2 years of directly related experience or Master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Project management skills. Strong organizational skills, including ability to follow assignments through to completion. Initiate and lead cross functional teams
Enhanced skills in leading, influencing, and negotiating. Strong knowledge in area of expertise. Collaborate and coordinate with higher level outside resources. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development. Demonstrated ability to interact with regulatory agencies. Strong word processing, presentation, database and spreadsheet application skills.

Strong communication (both written and oral), facilitation and presentation skills. Strong skill in working independently and to effectively interact with various levels. Advanced data trending and evaluation. Ability to evaluate compliance issues. Demonstrate the Client Values/Leadership Practices.

Farmacéutico Regente
Barceloneta, PR

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1. Have a valid license of PR Pharmacist in compliance with the requirements of Law No. 247 and requirement of “Colegio de Farmacéuticos de PR”.
2. Provide its license to the PR Department of Health on behalf of Client to obtain the license of manufacture, marketing, and distribution of the products in PR in accordance with Law No. 247.
3. Responsible for the site license annual renewal.
4. Have at least 3 years of experience in the pharmaceutical industry with knowledge in GMP.
5. Visiting the production areas at least one time a month to be familiar with the manufacturing and packaging processes and changes associated.
6. Participate in “Process Specific” training of production areas (Once per year with a duration of 1 to 2 days).

Validation Services
Guayama, PR

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The project consists of designing, installing, configuring, validating the new DC / AD and “moving” all of that equipment to that new DC / AD with the requirements and policies ofthe new company.

Resources will be working in the complete validation cycle, except generation of Change Control, according to the client’s procedures, which typically include: Impact Assessment, ERES Assessment, Validation Plan, URS, DS, FS, DS, Traceability Matrix, IOQ, IOA Report, VP Report.

Process Development Scientist – (29806)
Juncos, PR

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Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience.

Bachelor’s degree in Science (Statistics, Biology, Biochemistry, Math or Chemistry Preferred) or Engineering (Industrial Engineering Preferred).
Work on the Process Monitoring (Continue process verification) for Parenteral and Solid products. Provide support to investigations by participating in the root cause analysis. Own/lead investigations and corrective action implementations.

Requisites: Knowledge on parenteral and solid processes (Formulation, Granulation, Filling, Compression, Coating, etc.). Statistical knowledge and proficient in the use of Minitab and JMP, R-coding recommended. Knowledge in data retrieval/data analysis/presentation tools (OsiSoft PI, Spotfire, Smartsheet, Tableau etc), as well as MS Office (including Excel, Word and PowerPoint). Excellent technical writing skills. Fully bilingual (Spanish/English)- A portion of the interview will be conducted in English to evaluate the candidate.

Description:

To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor, Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors, or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project teamwork.

Doctorate degree or master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Advanced scientific analysis and troubleshooting skills.
Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others.
Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. Must have demonstrated skills and competencies in the following areas: Verbal communication Written communication including technical writing skills, negotiation and conflict resolution Analytical problem-solving Project management Ability to be flexible and manage change. Computer literacy (Windows environment: Word, Excel, Power Point). Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).

Specialist QA – (29814)
Juncos, PR

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Doctorate degree or Master’s degree and 3 years of Quality experience or Bachelor’s degree and 5 years of Quality experience.

•Engineering / Science related background.
•Experienced in Aseptic processing manufacturing processes.
•General understanding on Manufacturing Execution Systems (MES) and electronic Batch Records (e-BR).

Experience working on GMP regulatory and compliance manufacturing environments with a strong Quality mindset in the production of aseptically produced sterile biological drug products.

•Direct experience on Quality related matters associated to the GMP sustainability of pharmaceutical production areas.
•Capable to review and approve complex GMP documents from a Quality standpoint to ensure adherence to company policies, operating standards, procedures and/ or the applicable GMP document or project plan.
•Ability to conduct GMP quality inspections, walk downs and general oversight to production, utilities and general facility areas with the objective to ensure the required state of Validation.
•Knowledge on general Validation concepts (e.g. Process Performance Qualifications, Commissioning & Qualification and Validation Life Cycle Management for Equipment and Facilities including Computerized Systems) applied to GMP Pharmaceutical production areas required.
•Direct experience supporting multifaceted Validation projects from a Quality perspective and working with multidisciplinary teams on tight execution schedules.
•Ability to analyze, troubleshoot and solve quality related issues on a highly regulated GMP environment.
•General understanding around the process for the introduction of new products and new technology within commercial GMP areas.
•Ability to communicate and escalate quality issues clearly, with the required level of details and on a timely manner.
•Demonstrated ability to follow GMP procedures with a strong Quality and Compliance mindset.
•Project Management skills. Presentation Skills.
•Excellent Technical Writing and general Communication skills in English and Spanish.
•Information/Computer Systems knowledgeable.
•Good interaction skills to enable appropriate performance supporting complex matrix organizations.
•Capable to follow required Environmental Health & Safety procedures and related requirements within a GMP production environment.
•Ability to learn, execute and follow procedures related to Personnel Gowning for access to environmental controlled/classified rooms.
•Experience conducting quality audits to GMP production batch records and related supporting operational compliance documents for review and approval.
•Ability to work in teams and demonstrate full engagement with execution plans and adherence to established due dates.

Description:

Perform one or more of the following duties and responsibilities in support of Client’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation Ability to evaluate compliance issues, Demonstrate the Client Values/Leadership Practices.

Sr Validation Scientist – (29796)
Juncos, PR

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Doctorate degree in Sciences/Engineering or Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

Assembly, Tester and Packaging processes and machines support; Basic knowledge and experience on Medical Device/Combo Product processes and regulations; Basic metrology and testing experience; Validation and Characterization experience (Protocols/URS/DS/IOQ/PQ); Basic project management skills; Basic experience in medical device assembly process; Technical Report writing skills; Basic statistical knowledge; Basic Machine troubleshooting; Basic automation knowledge (PLC, HMI, Drivers, Motors, Profibus, Device Net, Control Net); Able to work in any shift as required by the projects and activities.

Description:

Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis. Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise. Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Prompt and regular attendance to the workplace.

*Other functions may be assigned

Knowledge:
Advanced validation knowledge (equipment qualification, cleaning, sterilization).
Applies extensive technical validation expertise, and has full knowledge of other related disciplines.
Problem Solving:
Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organization objectives.
Discretion/Latitude:
Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.
Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters.
Impact:
Essential to the completion of broad programs and projects.
Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.
Leadership:
Leads efforts of group of peers directly supervises staff or project resources.
Guides the successful completion of major programs and may function in a project leadership role.
May be expected to directly supervise staff or project resources.
Liaison:
Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
Regulatory:
Understands regulatory trends in industry and able to make connection between those trends and established corporate direction. Some direct experience with FDA or equivalent regulatory body.
Represents the organization as the technical expert to endorse the organization’s validation programs and practices

EDUCATION/LICENSES
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS
In-depth knowledge of validation processes and requirements
Interacts effectively with variety of communication and working styles
Ability to independently determine when additional internal resources are required to solve problems
Ability to handle multiple projects at one time
Demonstrated Skills in the following areas:
Schedule development
Facilitation
Collaboration
Basic project management
Completion and follow-up
Technical expertise areas of validation engineering.
Ability to independently determine when additional external resources are required to solve problems
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
Working knowledge of financial analysis tools
Ability to delegate and manage the project work of others
Demonstrated Skills in the following areas:
Negotiation, persuasion and facilitation
Collaboration
Project cost development
Conflict Resolution
Decision Making
Leadership and teambuilding
Management of contractors and vendors

Specialist QA – (29797)
Juncos, PR

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Master’s degree in Sciences/Engineering and 3 years of Quality experience or Bachelor’s degree in Sciences/Engineering and 5 years of Quality experience.
Experience in Quality services supporting Warehouse and Incoming operations as well as knowledge in ERP and QMTS systems (deviations, CAPA, Change Control) are preferred.

Description:

Perform one or more of the following duties and responsibilities in support of Client’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience. COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation Ability to evaluate compliance issues, Demonstrate the Client Values/Leadership Practices.

Process Development Scientist – (29741)
Juncos, PR

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Doctorate degree in Sciences/Engineering or Master’s degree in Sciences/Engineering and 3 years of validation experience or Bachelor’s degree in Sciences/Engineering and 5 years of validation experience.
Manual Visual Inspection and Automatic Visual Inspection processes, vision engineering, Cognex, vision systems, statistics (DOE, ANOVA).

Description:
To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor, Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Advanced scientific analysis and troubleshooting skills.
Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others.
Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. Must have demonstrated skills and competencies in the following areas: Verbal communication
Written communication including technical writing skills, negotiation and conflict resolution Analytical problem solving Project management Ability to be flexible and manage change. Computer literacy (Windows environment: Word, Excel, Power Point). Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).

Process Development Scientist – (29666)
Juncos, PR

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Administrative Shift – Non-Standard Shift

Doctorate degree Sciences/Engineering or Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 5 years of directly related experience.

(Biology, Biochemistry or Chemistry Preferred) or Engineering (Chemical or Mechanical Engineering Preferred)

Administrative hours and non-standard shift if needed (extra hours, weekend & holidays).
Experience supporting manufacturing operations in the following areas:

1. Formulation of Oral Parenteral Products
2. Vial Filing Process
3. Syringe Filling Process

The resources will provide day-to-day support to the commercial operations. Typical activities that will be conducting are:

1. On the floor support/troubleshooting activities of the formulation and filling process. Therefore experience in these areas is a must.
2. Provide support to investigations by participating in the root cause analysis, and providing product impact assessments
3. Own investigations and process monitoring assessments (knowledge of process monitoring, statistical knowledge and proficient in the use of minitab or JMP will be required)
4. Lead characterization activities by developing the design of the studies, protocol, training and execution of the characterization protocol
5. Excellent technical writing skills
6. Fully bilingual (Spanish/English)- A portion of the interview will be conducted in English to evaluate the candidates

Description:

To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor, Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Advanced scientific analysis and troubleshooting skills.
Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others.
Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. Must have demonstrated skills and competencies in the following areas: Verbal communication Written communication including technical writing skills, negotiation and conflict resolution Analytical problem solving Project management Ability to be flexible and manage change. Computer literacy (Windows environment: Word, Excel, Power Point). Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).

Sr Specialist QA – (29815)
Juncos, PR

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Doctorate degree and 2 years of directly related experience or master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience.
•Engineering / Science related background.
•Experienced in Aseptic processing manufacturing processes.
•General understanding on Manufacturing Execution Systems (MES) and electronic Batch Records (e-BR).

Experience working on GMP regulatory and compliance manufacturing environments with a strong Quality mindset in the production of aseptically produced sterile biological drug products.
•Direct experience on Quality related matters associated to the GMP sustainability of pharmaceutical production areas.
•Capable to review and approve complex GMP documents from a Quality standpoint to ensure adherence to company policies, operating standards, procedures and/ or the applicable GMP document or project plan.
•Ability to conduct GMP quality inspections, walk downs and general oversight to production, utilities, and general facility areas with the objective to ensure the required state of Validation.
•Knowledge on general Validation concepts (e.g. Process Performance Qualifications, Commissioning & Qualification and Validation Life Cycle Management for Equipment and Facilities including Computerized Systems) applied to GMP Pharmaceutical production areas required.
•Direct experience supporting multifaceted Validation projects from a Quality perspective and working with multidisciplinary teams on tight execution schedules.
•Ability to analyze, troubleshoot and solve quality related issues on a highly regulated GMP environment.
•General understanding around the process for the introduction of new products and new technology within commercial GMP areas.
•Ability to communicate and escalate quality issues clearly, with the required level of details and on a timely manner.
•Demonstrated ability to follow GMP procedures with a strong Quality and Compliance mindset.
•Project Management skills. Presentation Skills.
•Excellent Technical Writing and general Communication skills in English and Spanish.
•Information/Computer Systems knowledgeable.
•Good interaction skills to enable appropriate performance supporting complex matrix organizations.
•Capable to follow required Environmental Health & Safety procedures and related requirements within a GMP production environment.
•Ability to learn, execute and follow procedures related to Personnel Gowning for access to environmental controlled/classified rooms.
•Experience conducting quality audits to GMP production batch records and related supporting operational compliance documents for review and approval.
•Ability to work in teams and demonstrate full engagement with execution plans and adherence to established due dates.
•Strong engagement and partnership with site Management.

Description:
In support of Client’s Quality Assurance program acts as the technical specialist. Review and approve product MP’s. Approve process validation protocols and reports for mfg. Processes. Represent Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Own site quality program procedures. Designee for QA manager on local CCRB.
Doctorate degree and 2 years of directly related experience or master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Project management skills. Strong organizational skills, including ability to follow assignments through to completion. Initiate and lead cross functional teams
Enhanced skills in leading, influencing, and negotiating. Strong knowledge in area of expertise. Collaborate and coordinate with higher level outside resources. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development. Demonstrated ability to interact with regulatory agencies. Strong word processing, presentation, database and spreadsheet application skills.

Strong communication (both written and oral), facilitation and presentation skills. Strong skill in working independently and to effectively interact with various levels. Advanced data trending and evaluation. Ability to evaluate compliance issues. Demonstrate the Client Values/Leadership Practices.

(RESUME BANK) Project Manager
Puerto Rico

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Location: Puerto Rico
Primary Responsibilities:
• Coordinate internal resources and third parties/vendors for the flawless execution of projects
• Ensure that all projects are delivered on-time, within scope and within budget
• Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility
• Ensure resource availability and allocation
• Develop a detailed project plan to monitor and track progress
• Manage changes to the project scope, project schedule and project costs using appropriate verification techniques
• Measure project performance using appropriate tools and techniques
• Report and escalate to management as needed
• Manage the relationship with the client and all stakeholders
• Perform risk management to minimize project risks
• Establish and maintain relationships with third parties/vendors
• Create and maintain comprehensive project documentation
• Meet with clients to take detailed ordering briefs and clarify specific requirements of each project
• Delegate project tasks based on junior staff members’ individual strengths, skill sets and experience levels
• Track project performance, specifically to analyze the successful completion of short and long-term goals
• Meet budgetary objectives and make adjustments to project constraints based on financial analysis
• Develop comprehensive project plans to be shared with clients as well as other staff members
• Use and continually develop leadership skills
• Attend conferences and training as required to maintain proficiency
• Perform other related duties as assigned
• Develop spreadsheets, diagrams and process maps to document needs
Minimum Qualifications:
• Education: Bachelor’s degree in Architecture, Engineering or Construction Management
• Experience: At least 4 years of Construction Project Management
Preferred Qualifications:
• Certification: Project Management Professional (PMP) certification (preferred)
• OSHA 30-hour certification
• Computer literacy (Microsoft Office – Word, Excel, and PowerPoint, Outlook, Internet, etc.).
• Specific software literacy (Primavera 3/6, MS Project, AutoCAD, Viewpoint, BIM, Revit).
• Must have excellent documentation and organizational skills.
• Knowledge of acceptable site practices including OSHA Safety Regulations.
• Ability to communicate with both internal and external clients and co-workers.
• Have a thorough working knowledge of Project Management requirements.

(RESUME BANK) Project Engineer

Puerto Rico

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We are seeking available Project Engineer contractors who would like to be considered for project opportunities in 2020 and would like to be added to our resume database.

Location: Puerto Rico
Primary Responsibilities:
• Completes engineering projects by organizing and controlling project elements.
• Develops project objectives by reviewing project proposals and plans and conferring with management.
• Determines project responsibilities by identifying project phases and elements, assigning personnel to phases and elements, and reviewing bids from contractors.
• Determines project specifications by studying product design, customer requirements, and performance standards.
• Completes technical studies and prepares cost estimates.
• Confirms product performance by designing and conducting tests.
• Determines project schedule by studying project plan and specifications, calculating time requirements, and sequencing project elements.
• Maintains project schedule by monitoring project progress, coordinating activities, and resolving problems.
• Controls project plan by reviewing design, specifications, and plan, scheduling changes, and recommending actions.
• Controls project costs by approving expenditures and administering contractor contracts.
• Prepares project status reports by collecting, analyzing, and summarizing information and trends; recommending actions.
• Maintains safe and clean working environment by enforcing procedures, rules, and regulations.
• Maintains project data base by writing computer programs; entering and backing up data.
• Maintains product and company reputation by complying with federal and state regulations.
• Contributes to team effort by accomplishing related results as needed.

inimum Qualifications:
• Education: Bachelor’s degree in Architecture, Engineering or Construction Management
• Experience: At least two years of experience in the construction field.

Preferred Qualifications:
• OSHA 30-hour certification
• Highly proficient in use of Microsoft Office
• Strong organizational / time management skills
• Familiar to proficient with construction software (Bluebeam, MS Project or P6)
• Construction trade / jobsite knowledge / familiarity (Contract documents and drawings, cost estimating, construction jobsite / field experience, equipment / materials)

(RESUME BANK) Process Development Scientist

Puerto Rico

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BS in Engineering (preferred in Mechanical or Chemical Engineering) or Life Sciences (preferred on Biology, Chemistry, Microbiology) and 5 years of Scientific experience.
Experience in Vial or Syringe Filling, Isolator Technology, Vial or Syringe Filling Characterization, Vial or Syringe Filling Validation.

To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor, Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Advanced scientific analysis and troubleshooting skills. Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others. Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. Must have demonstrated skills and competencies in the following areas: Verbal communication Written communication including technical writing skills, negotiation and conflict resolution Analytical problem-solving Project management Ability to be flexible and manage change. Computer literacy (Windows environment: Word, Excel, Power Point). Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).

(RESUME BANK) Sr. Computer Validation Specialist

Puerto Rico

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Qualifications:

Bachelor’s degree in engineering, computer science or related field. 5 years’ Experience with validating computer and Automation Systems in Manufacturing equipment such as Blenders, Tablet Press, Granulators, Encapsulators, Film Coaters. Technical writing skills for the creation of protocols. Team working – Work in teams to gather and analyze data and Protocol Execution, Keen attention to detail – Must be able to quickly spot when something isn’t correct and take effective action. Good communication skills – This role requires working with people from across the manufacturing process and often working with production staff to discuss projects, adherence to protocols and implementing. Excellent written communication – Documentation is essential requirement for compliance with emphasis in attention to details creating documentation. Prioritization skills – Working with project deadlines and ensuring the manufacturing process is working efficiently at every stage, must be able to prioritize workload.

Responsibilities:

SME for Generation and execution of CSV protocols. The Computer Systems Validation (CSV) position will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and 21 CFR Part 11 and Data Integrity related documentation such as assessments, plans, URS, FRS, RTM, UATs, OQs and summary reports.

(RESUME BANK) Quality Control Scientist

Puerto Rico

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• Technical evaluation of chemical analytical methods to determine reagents / equipment to be used, assure acquisition and deployment, develop and/or revise analytical methods Quality Standards documents.
• Determine and delineate proper implementation of the analytical methods (method transfer, validation or verification). Prepare method validation protocols, determine specifications, data evaluation, and execution of final reports and assure proper laboratory deployment of the method.
• Reports / collects / evaluates laboratory data to support cleaning process implementation.
• Coordinates / delineates / conduct laboratories works in collaboration with Quality Laboratory Analysts to collect / generate the necessary data, data evaluation and prepare the corresponding reports to support conclusions and recommendations according to the tasks assigned.
• Perform other job-related tasks as required.
• Comply with all safety and environmental guidelines, procedures, training, practices, permit conditions, and internal notification of any safety and environmental events.

Education and/or Experience:

Bachelor Degree in Science with Chemistry major (preferably).
Five (5) or more years processing experiences in Quality Control or Technical Operations is preferred or equivalent combination of education and experience.
The incumbent must have experience in product introduction and transfer, developing and validating analytical methods demonstrating skills necessary to build and maintain a high-performance.
Willing to work irregular and/or extended shifts if needed.
Able to work under pressure with minimum supervision and able to meet deadlines.

Computer Knowledge/Specific Skills:

Knowledge of Good Manufacturing Practice regulations, EPA regulations, Laboratory Safety Rules, OSHA regulations, classical and modern analytical chemistry or microbiology and sophisticated instrumental techniques.
Work experience with Office (Word, Excel, PowerPoint, and Outlook).
Minitab or any other statistical application.

(RESUME BANK) QA Specialist

Puerto Rico

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• Bachelor’s degree in Life Science or Engineering and 5 years of Manufacturing or Quality in GMP regulated environment experience.
• Project management skills
• Strong organizational skills, including ability to follow assignments through to completion
• Collaborate and coordinate with higher level outside resources
• Strong knowledge of and experience with processes involved in manufacturing, QA, QC, validation and process development
• Demonstrate ability to interact with regulatory agencies
• Strong word processing, presentation, database and spreadsheet application skills
• Strong skill in working independently and to effectively interact with various levels
• Ability to evaluate compliance issues

Description:

Perform one or more of the following duties and responsibilities in support of Client’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation
Ability to evaluate compliance issues, Demonstrate the Client Values/Leadership Practices.

(RESUME BANK) Sr. Automation Engineer

Puerto Rico

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Qualifications:
• Bachelor’s Degree in Engineering or Computer Science Required:
• Subject Matter Expert on PLC/SCADA system code development, testing, qualification.
• Good communication skills.
• Ability to participate in and lead highly effective teams.
• Ability to become influential in his/her area demonstrated by suitable technical degrees and/or experience.
• Ability to work with all levels of business customers in a highly dynamic environment.
• Strong leadership and interpersonal skills in motivating staff and customers in the achievement of shared objectives.
• High personal integrity, credibility, and energy.
• Ability to integrate diverse initiatives across systems development groups, business and client organizations, and infrastructure areas.
• Experience and in-depth understanding of System Development Life Cycle (SDLC) and application systems development.
• Good project management experience in relation to scope, cost, and schedule control of large automation capital projects.
• A minimum of 3 years manufacturing or related experience is required.
• Experience with automation systems for pharmaceutical facilities is required.
• In-depth understanding of System Development Life Cycle (SDLC) and applications systems development is required. Preferred:
• A minimum of 10 years in automation is strongly preferred.
• Experience and accomplishments in the project management of manufacturing automation/ execution systems.
• Other information technology experience is a plus

Responsibilities:

Automation project support role for various scale manufacturing automation projects to ensure the projects are delivered of high quality. This includes following the project through multiple phases of a project life-cycle including requirements, design, testing, installation, qualification and training. It will involve working closely with the customer, technical staff, other engineering groups and the management of suppliers to ensure a successful implementation. Major Projects include automating production of key Client products in all three areas of Manufacturing.

Projects will be for Human Health Pharmaceutical facilities and employing technologies including: Supervisory Control and Data Acquisition Systems (SCADA)
•Manufacturing Execution Systems (MES)
•Process Data Management Systems
•IT Integration Services The candidate could also serve as the Automation/IT Project Manager on a small sized project, to ensure that the project is delivered within cost and on schedule. The candidate must also understand the business needs of MMD and stay abreast of new technologies to make recommendations for business improvements. Candidate should be familiar with the application of SDLC Methodology and computer validation concepts. Candidate must possess good communication skills.

(RESUME BANK) Sr. Validation Scientist

Puerto Rico

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Bachelor’s degree in Life Sciences or Engineering and 5 years of Scientific experience OR Master’s Degree in Life Sciences or Engineering and 3 years of Scientific experience.
Cleaning and/or Sterilization knowledge.

Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis. Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise. Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Prompt and regular attendance to the workplace.