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

Handyman/Pintor
Area Geográfica: Vega Baja, PR

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Estamos identificando recursos para cubrir cuatro (4) oportunidades de Handyman para el área de Vega Baja.

Debe poseer licencia de conducir vigente, certificado de antecedentes penales actualizado.
Responsable, organizado y con mucha iniciativa.
Realizará trabajos de pintura, trabajos de plomería, trabajos de electricidad, mantenimiento general en reparación, conservación y modificaciones menores de las instalaciones, reparaciones de paredes/plafones gypsum board y otras tareas relacionadas.

Reparador(a) Puertas de Manufactura
Area Geográfica: Manatí – Vega Baja, PR

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Tres años o más de experiencia en la reparación y el mantenimiento de puertas de manufactura. Experiencia en “rolling doors”, “sliding doors”, “fire doors”, etc.

Accounting Manager (29368)
Juncos, PR

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Doctorate degree in Accounting or master’s degree in Accounting & 3 years of directly related experience or bachelor’s degree in Accounting & 5 years of directly related experience.
PR Tax Corporations compliance experience and tax regulation basic knowledge (specific taxes on: sales use tax, property tax, patente tax and withholding tax)
SAP knowledge preferred
Experience with external audits compliance (prepare audit schedules)

Basic Functions
1. Prepare tax package information as requested by the ATO tax team
2. Prepares account analysis and corporate tax schedules for Corporations tax, personal and real property,
volume of business and exempt reporting.
3. Prepare and update tax provision schedules
4. Coordinate audits request by taxation authorities
5. Research and new tax regulation and legislations
6. Respond to customer inquiries, State and Local tax notices
7. Prepare tax forecast for foreign excise and corp. taxes.
8. Perform accounting for the client branches doing business in Puerto Rico
9. Prepare annual reporting filing for non-resident entities
10. Support the new VAT system for the site and the client entities doing business in PR.
11. Request/ submit monthly and quarterly tax payments, as required

Description:
Provide complex account analyses and journal entries and may supervise/manage and review accounting staff and analyst work. Functions: Prepare and review complex journal entries. Perform and review complex general ledger account analysis and reconciliation. Prepare and review audit schedules and answer complex questions from internal and external auditors. Preparation and review of complex financial schedules such as footnote, month-end flash reports, LE (latest estimate) support and other ad hoc schedules. May supervise/manage and review accounting control functions and reporting requirements such as: Corporate partner billings, Royalties, Dept. of Commerce filings, Sales & Use tax returns, Responds to internal client staff complex questions regarding accounting issues,
Special projects may be assigned. Education/Licenses: Doctorate degree or master’s degree & 3 years of directly related experience or bachelor’s degree & 5 years of directly related experience or Associate’s degree & 10 years of directly related experience or High school diploma / GED & 12 years of directly related experience.

Competencies/Skills:
Excellent computer skills including spreadsheet software, Excellent data analysis skills, Strong communication skills including written and verbal, Basic presentation skills, Good financial business understanding, Strong organizational skills, Strong understanding and application of basic accounting principles including GAAP (Generally Accepted Accounting Principles), Ability to demonstrate judgment and make appropriate recommendations, Develop and maintain operational processes and procedures, Ability to work effectively with senior management.

Sr. Quality Engineer (29363)
Juncos, PR

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

• Demonstrated skills in the following areas:
o Problem solving and applied engineering
o Basic technical report writing
o Verbal communication
o Computer Literacy
o Technical presentations
o Statistical analysis
o Analytical Problem Solving
• Comprehensive understanding Quality Engineering processes and programs
• Interacts effectively with variety of communication and working styles
• Highly preferred: knowledge of Statistics with experience in computer programming such as R, Tableau, Python
• Administrative Shift Yes

Description

With general guidance, provides direct technical Quality Engineering of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environments. Able to provide process map of complex processes. Applies Six Sigma tools and scientific principles to the design and implementation of system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or Quality Engineering projects of moderate scope and complexity. Provide solutions/improvement proposal to a variety of highly complex technical processes of moderate scope. Independently evaluate, select, and/or modify Quality Engineering metrics/analysis/techniques, procedures and criteria. Perform assignments that have loosely defined objectives that require investigation of a large number of variables. Interpret and execute policies and procedures. Recommend modifications to operating policies. Function as a Quality Engineer expert to equipment, processes, or systems regarding troubleshooting and operations. Occasionally become actively involved in daily operations when required to meet schedules or to resolve complex problems. Routinely audit the status of the improved systems and regulatory compliance of a large number of highly complex equipment items or systems. Lead efforts with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for system modifications. Execute tasks under the general direction of project managers to complete the responsibilities of Quality Engineering, and construction projects within schedule and budget constraints. Develop small to intermediate project scopes, schedules and budgets within area of expertise. Prompt and regular attendance to the workplace. Other functions may be assigned. American Society for Quality (ASQ) Certified Quality Engineer (CQE)/ Certified Black Belt body of knowledge. Applies extensive technical expertise and analysis and has knowledge of other related disciplines. Make decisions independently regarding Quality Engineering Projects complexities and methods.
Devises new solutions to problems encountered. Discretion/Latitude: Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives. Plans and conducts own work. Independently performs most assignments with instruction only regarding general expected results. Receives technical guidance for unusual or complex problems and supervisory approval of proposed project plans. Contributes to the completion of specific programs and projects. Decisions, recommendations and actions are essential to the successful completion of program schedules and utilization of personnel and fiscal resources. Capable of setting priorities and leading initiatives and/or projects. May be expected to directly supervise staff or project resources. Frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects. Detailed understanding of GMPs. Able to interpret CFRs in establishing current practices. Interactions expected with regulatory agencies as related to areas of responsibility.
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 Working knowledge of applying six sigma statistical tools, processes and programs. Familiarity with pharmaceutical/biotech processes. Familiarity with documentation in a highly regulated environment, Ability to work on specialized statistical software such as Minitab as appropriate. Ability to analyze and apply GLPs and GMPs to improve the quality of the system. Ability to apply industrial engineering and process improvement to production. Able to develop solutions to routine technical problems of limited scope. Demonstrated skills in the following areas: Problem solving and applied engineering. Basic technical report writing. Verbal communication. Computer Literacy. Inter-personal skills. Comprehensive understanding Quality Engineering processes and programs. Demonstrated skills in the following areas: In-depth knowledge of 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, Schedule development, Facilitation, Collaboration, Basic project management, Completion and follow-up.

Supply Chain Manager (29390)
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.
Specific educational background you highly preferred
Preferred Industrial Engineer or Business Administration
Preferred Background in Supply Chain Transportation processes (Documentations, Carrier Bookings, Budget Management)
OPEX background or Lean Six Sigma Certification

Budget Creation & Management
Presentation Skills
Self-Motivated
KPI Manager
Administrative Shift
Under minimal supervision provides Supply Chain work group supervision and technical expertise in support of successfully completing daily operations within scope of responsibility. Ensures all work is completed with minimal disruption and in compliance with all cGMP guidelines and Client procedures. Direct and coordinate daily activities of personnel responsible for material receipt, storage and transport. Ensures materials are received, stored and transported according to established performance standards and all applicable procedures and regulations. Interacts with internal and external regulatory agencies to ensure compliance with cGMP, DOT, OSHA requirements. Collaborate with other sites to maintain optimal flexibility for the storage of all materials and product. Identify and oversee implementation of new and improved business and compliance systems and tools. Partner with key internal customer groups and/or external suppliers to ensure successful operations and performance targets are achieved.
Responsible for business continuity programs for assigned areas. Participate on global functional teams to coordinate and improve the transportation and Logistics of material movement and storage across the Client Supply Chain.
Direct and coordinate daily activities of personnel responsible for developing and managing Product demand and forecasts. Organize and communicate on a regular basis the total demand and supply requirements to senior management. Coordinate the Master Production Schedule for Finished Goods and effectively communicate any impact created by, and to the supply plan. Manage the process of gathering, evaluating and feedback of global demand requirements. Provide and coordinate the development of business case scenarios that demonstrate the impact of current or proposed operations plans. Manage the preparation and communication of the Company wide Inventory Distribution Plan to achieve corporate goals of customer satisfaction and risk management.
Develop and coordinate the long-range production requirements based on Marketing forecasts, product approval and release timelines, clinical requirements, SKU put-up information and business planning timelines estimates.
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
Must have well developed skills from Supervisor I level in addition to the following: Facilitation and presentation skills, Strong analytical problem solving skills, Strong technical writing skills, Strong project management skills, Change management skills, Ability to influence staff and effect change outside of area of responsibility, Initiate and lead cross-functional teams to resolve complex issues, Good decision making skills, Technical expert for function, Possess an understanding and appreciation of the Client Values and Leadership Attributes, While performing the duties of this job, the environment for the staff member is of an office atmosphere. Computer terminals, telephones, and calculators are in use constantly. Assignments are received in task and objective oriented terms. Provides direction to subordinates using established policies and procedures. Work is reviewed upon completion for adequacy in meeting the task / objective. Administers policies and procedures that typically affect individual staff members within one or more functional work groups. Accomplishes tasks mainly through general supervision of nonexempt and experienced exempt employees. Monitors daily operations of a work group and actively assists, or provides direction to, subordinates as required. May perform ongoing operational tasks. Makes decisions regarding group operations. Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources. Ensures tasks and projects are efficiently completed on schedule following established procedures and within budget. Majority of liaison is on internal basis with subordinates and supervisors at equivalent level or one level higher. Regularly conducts briefings to management. Liaison normally involves specific phases of a project or operation. External contacts are regular and generally involve coordinating operational issues.

Cleaning Validation SME
SouthWest, PR region

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Must have extensive experience with the Assessment, Design, Implementation, Validation of a cleaning validation program from scratch.

Science and/or Engineering bachelor’s degree plus 15 plus years of experience with STRONG expertise with the Design & Implementation of cleaning Validation programs.

QC Laboratory Associate Supervisor
Arecibo, PR

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• Bachelor’s Degree in science, Chemistry (with current PR Chemist License preferred).
• Minimum of one to three (1-3) years of previous analytical service laboratory supervisory experience.
• Under the direction of the QC Laboratory Supervisor, the incumbent is responsible for the safe, efficient and effective operation of the laboratory areas on the assigned shift.
• This responsibility includes the testing of materials associated to their area (such as In-process, Raw Materials, Stability, and Finished Goods).
• Assists in the coordination of activities associated to the laboratory personnel and reviews test reports, as required. Ensure completion of Laboratory metrics.
• Participates in the hiring, training and development of Laboratory Analysts and Chemists.
• Reviews and approves protocols and reports, deviations, and any other documentation associated with the QC Laboratory, as required.
• Ensure site’s business continuity by providing on-time required Laboratory services.
• Puerto Rico Chemist License preferred.
• Willing to work rotating shifts.
• Fully bilingual; good oral and written communications skills in English and Spanish. Ability to read and interpret documents such as safety rules, personnel policies and procedures manuals.

Description
1. Assists in the coordination of the testing requirements associated with commercial and new products projects.
2. Participates in meetings associated with their area of responsibility, as required by the QC Laboratory Supervisor.
3. Review and/or revision of the applicable procedures, Quality Standard (QS), guidelines and policies, etc., as required.
4. Reviews and/or updates the sampling and testing plans of their area, as required.
5. Assists in the coordination of maintenance of adequate supplies of test solutions, reference standards, reagents chemicals and spare equipment by requesting these items in anticipation to their needs.
6. Reviews and/or prepares the necessary analytical reports associated with their area of responsibility.
7. Assures all personnel comply with GMP requirements in the QC Laboratory.
8. Revise and approves installation and qualification protocols for laboratory instruments
9. Provides personnel training related to Methods, pharmacopoeias and related documents changes, as required.
10. Under the direction of the QC Laboratory Supervisor, uses statistical methods to diagnose and correct improper quality control practices using analytical data to provide the best service and identify areas of opportunity and efficiency along with our clients.
11. Excellent interpersonal and good supervisory skills.
12. Manage multiple projects at the same time with minimum supervision and incorporate a wide array of technical principles, concepts and theories in innovative ways. Work under pressure, self–starter, demonstrates analytical and problem-solving skills.
13. Ability to teach others and transfer knowledge to end users.
14. Speaks effective and fluently to a group with the capacity to listen, understand information and ideas presented through spoken words and sentences.
15. Work cross functionally within an organization, being able to impact and influence other management teams that do not report to this position.
16. Possess regulatory (FDA) industry experience, familiarity with cGMP’s, GAMP (Good Automated Manufacturing Practice), Laboratory Equipment/Instrumentation C&Q practices (Commissioning & Qualification), EPA regulations, Laboratory safety, OSHA Rules, and control substances (DEA). Understand and resolve complex and critical QC analytical problems concurrent to Pharmacopeias requirements, changes and modifications.
17. Proven ability to learn new computer software/systems and laboratory instruments with minimum guidance and general understanding of SLC (system life cycle) and CSV (computer system validation).
18. Knowledge and experience with systems and validation processes.
19. Skills in MS Office Suite applications of MS Project, Outlook, Word, Excel and PowerPoint, skills at performing data evaluation, formulas and metrics.
20. Good organization and time management skills with the ability to adapt to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
21. Comply with all environmental trainings, procedures, guidelines, practices, current Good Manufacturing Practices (cGMP’s), permit conditions and internal notifications of any environmental event.
22. Able to move between areas.
23. Willing to travel (If required).
24. Maybe exposed to toxic substance in access-controlled areas.
25. Maybe exposed to closed areas.
26. Use the safety equipment accordingly to the restricted areas and products requirements.

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.

Maintenance Technician

Arecibo, PR

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Requirements:
 Education – Technical course or associate degree in Electricity and authorized to work as electrician based on local codes.
 At least 5 years of experience in a similar position in a manufacturing or pharmaceutical company.
 Proficient in English and Spanish (read and write).
 Ability to read and understand technical material in both languages, English and Spanish.
 Knowledge/Skill to communicate using e-mail and other electronic tools available.
 Basic knowledge in PLC system (maintenance and/or programming), instrumentation and mechanical systems (pumps, compressor, others).
 Ability to analyze scope of works and determinate the actions needed to complete it on time, in compliance and without an accident.
 Ability to perform investigation related to critical equipment’s and/or system using tools such as 5 whys DMAIC and others.
 Full-time, non-exempt. Available to work all shifts.

Essential Functions and Scope:
1. Available to work any shift including overtime, weekends and holidays.
2. Perform/support maintenance activities related to manufacturing, utilities and facilities systems and document the activity performed in the CMMS.
3. Perform troubleshooting to electrical and mechanical equipment’s to identify failure and/or execute the necessary actions to address problem.
4. Follow and foment safety requirements and always use the necessary PPE while performing an activity.
5. Coordinate and perform predictive maintenance activities including, vibration analysis, thermography, ultrasound and laser alignment.
6. Accountable for all maintenance activities related to the electrical system and/or electrical equipment within the site.
7. Perform maintenance activities to mechanical system including piping, pumps, AHU, cooling towers and other utilities/systems as needed.
8. Perform maintenance/repairs to controls system such as PLC, DCS, pneumatic control (valve) and VFD.
9. Proficient with the use of drawings including, P&ID, electrical, pneumatic electronic and hydraulic.
10. Support other departments based on company needs and foment teamwork environment.
11. Use appropriate equipment’s to perform the necessary troubleshooting including, multimeter, oscilloscope, megger and others.
12. Install conduit and wiring to existing and/or new equipment’s including, control systems, lighting, transformer, motors, VFD and others.
13. Accountable for the maintenance related to the site electrical system (high and medium voltage).
14. Always comply with training requirements, SOP, cGMP, work permit requirements and environmental policy.
15. Perform other activities related to his role based on company need and/or supervisor request.

Sr. Computer Validation Specialist III Senior #27549

Las Piedras, PR

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Qualifications:
Bachelor’s degree in engineering, computer science or related field. Knowledge in Lab X. 5 years of Experience with validating Laboratory equipment such as IR and Titrators. Knowledge of OMNIC, TIAMO, CS suite, Qdoc or Data Pro Heavily preferred.
Administrative Shift

Responsibilities:
SME for Generation and execution of CSV protocols

Cleaning/Process Validation Specialist

Barceloneta, PR

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Must have 5 plus years of Cleaning/Process validation experience in the pharmaceutical industry with Cleaning/Process validation.

Estimated contract of 6 months

(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.