DMCG Careers

Operations technicians are members of shift teams who monitor and operate the facilities of work platforms, often working in cooperation with engineering and construction teams. Their main responsibilities are to maintain plant integrity and ensure a reliable availability of supplies to customers.

They do this by troubleshooting mechanical problems and performing maintenance to reduce rig downtime. Some of their common job responsibilities include:

• Being accountable for the day-to-day management of pipeline operations activities
• Managing their own work area
• Third shift Position
• 24/7 Operation
• Troubleshooting any production disturbances that may occur
• Waste Water License and Potable Water License
• Starting and stopping production facilities
• Carrying out routine and first-line maintenance as needed
• Gathering information, preparing and tracking permit applications
• Being familiar with all mechanical equipment located onboard an offshore installation
• Completing integrity and performance well tests
• Filing various monthly, quarterly, and annual reports concerning production
• Participating in team troubleshooting of equipment and processes
• Leading pigging operations
• Continually monitoring safety system status
• Communicating with supervisors about all activities relating to operations
• Forming part of emergency response team
• Reporting risks and incidents to the appropriate personnel
• Maintaining equipment history and all other relevant records mostly in Maximo system

Quick Fact: Operations technicians are sometimes required to climb to heights in excess of 200 feet, lift 50 pounds or more, and stand for long periods of time.

BS in Engineering, 5 years plus of project engineering capital projects with pharmaceutical industry.
Strong interpersonal, teamwork and problem-solving skills. Strong verbal and written communication skills. Demonstrated ability to manage multiple priorities in different capital projects.

•Fulfills project engineer duties for large/small complex capital projects such as:
 -Permits issue
-Contractors coordination
 -Team oriented
•Assists with reporting and reacting to appropriate metrics for measuring and improving success
of strategies implemented.
•Work closely with customers to understand their needs and respond accordingly to develop the
appropriate field projects adjustments.

– Must have an Engineering BS, with 10 plus years of experience performing a similar position in the pharmaceutical manufacturing industry.
– Works closely with production and the maintenance scheduler, planner, mechanics / technicians to establish short-term and long-term priorities to optimize OEEs and meet production schedule.
– Assure facilities are at GMP standards always.
– Ensures appropriate utilization of maintenance mechanics / technicians to support maintenance projects, emergency work, preventive maintenance, reliability maintenance and maintenance evaluations.
– Proactively identifying, correcting and execute action plan to correct maintenance issues that could negatively impact production, equipment OEE and GMP standards.
– Inspected and monitored safety systems, HVAC equipment, and fire riser/sprinkler systems.
– Performed daily reports on property status and made any arrangements needed for work by outside contractors.
– Performed routine maintenance to ensure all systems worked properly and served on-call 24/7 in the event of emergency.

Responsable de realizar tareas de manufacturas especializadas en la operación. Es responsable de informar inmediatamente cualquier evento o incidente de seguridad. Estar dispuesto a trabajar bajo el mínimo de supervisión directa y poseer buenas destrezas analíticas. Se requiere que utilice el uniforme provisto por la compañía, además el código de vestimenta en áreas específicas.

TAREAS Y RESPONSABILIDADES ESENCIALES

1.Trabajar turnos rotativos (incluyendo los fines de semana) y horarios extendidos.
2.Apoyar y/o participar en las soluciones de problemas (troubleshooting) de los equipos requeridos para la manufactura; incluyendo entradas de datos documentos y/ o sistemas computadorizados, seguimiento estricto de procedimientos escritos.
3.El operador farmacéutico es responsable por la preparación y mantenimiento de las áreas de trabajo. Responsable de promover las buenas relaciones profesionales de trabajo en el grupo.
4.Ensamblar y desmontar el equipo mecánico para las operaciones de limpieza según requerido.
5.Asegurar el cumplimiento de la Descripción de Proceso de Manufactura (MPD – Manufacturing Process Description) y los procedimientos estándares de operación y mantener informado al supervisor o designado de condiciones anormales que surja en el proceso.
6.Proveer apoyo en otras actividades de calidad tales como la evaluación de la elegancia de las tabletas, muestreo estadístico, muestreo microbiológico usando técnicas asépticas u otras actividades según requeridas por personal cualificado.
7.Asistir al personal técnico en las validaciones y en las calificaciones del área según requerida.
8.Ejecutar transacciones de materiales a través del sistema computadorizado según requerido. Reconciliación de materiales y manejo de control de inventario computadorizado, muestreo durante el proceso de manufactura.
9.Seguir los procedimientos de seguridad generales de la planta, tal como los pasos de “Cierre y
etiquetado” (lock-out, tag-out) además del mantenimiento de su equipo personal de seguridad. Participación en inspecciones y auditorias de Seguridad y Ambiental, inspecciones de calidad.
10.Apoyar el equipo de personal exento en las investigaciones y documentación de las desviaciones al proceso del área de manufactura, además, de apoyar la implementación de las acciones correctivas.
11.Informar al dispensario médico de cualquier condición médica que pueda afectar la buena ejecución de sus tareas. Informar al supervisor o designado de cualquier incidente que ocurra en su área de trabajo que pueda representar una condición peligrosa de su persona y / u otros empleados. Notificar accidentes inmediatamente al supervisor.
12.Monitorear todo parámetro regulatorio de los instrumentos y equipo para asegurar cumplimiento como temperatura, porciento de humedad relativa, presión diferencial, etc.
13.Participar y sustentar el proceso de mejora continua del área.
14.Cumplir con todos los entrenamientos, procedimientos, directrices, practicas, buenas prácticas de manufactura (cGMP’s), condiciones de los permisos ambientales y notificaciones internas de cualquier evento ambiental.
15.Ejercer otras funciones relacionadas con el trabajo, según se requiere o que puedan surgir en el futuro.

REQUISITOS DEL PUESTO

Para ejecutar este puesto, el/la incúmbete debe poseer la habilidad de desempeñar cada área esencial de forma satisfactoria. Los requisitos que siguen son representativos del conocimiento, destrezas y/o habilidades requeridas. Podrán hacerse acomodos razonables para que personas con impedimentos puedan desempeñar las tareas esenciales.

EDUCACIÓN Y/O EXPERIENCIA

Grado Asociado en Ciencia, Química, Procesos Químicos o alguna ciencia de ingeniería.
Mínimo de un (1) año de experiencia en manejos de equipos relacionados a operaciones farmacéuticas (i.e compresión de tabletas, encapsuladores, equipos de revestimientos, granuladores, secadores, mezcladores de líquidos y sólidos y sistemas computadorizados (i.e. Excel, otros) preferible. De no tener experiencia, tener un perfil de trabajos científicos, proyectos, etc. (presentar evidencia).

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.

The role is responsible to support and lead all aspect of the Commissioning and Qualification (C&Q) program Life Cycle from design through operation and maintenance. The role will develop and manage the commissioning and qualification program of the site. The resource will assure the compliance with cGMP, GAMP and ISPE guidelines. The role is responsible to prepare site validation documentation such as User requirements, design and functional specifications, qualification protocols, master plans, risk assessments, periodic reviews, among others. The resource will coordinate the work of contractors for multiple projects and will assure the projects are well documented in the site change control system. The resource could support for a limited time other functions such as project management and technical evaluations for the site.

A bachelor’s degree in Science such as Pharmacy, Engineering, Biotechnology, Chemistry, Physics or Biology. Minimum of 5 years of experience in a highly-regulated industry like Pharmaceuticals and/or Medical Device. Knowledge in cGMP, GAMP, ISPE and computerized system life cycle guidelines. Knowledge on site utilities (HVAC, Compressed air, Purified water, etc). and facility is required.

The position will help the site in completing Commissioning and Qualification activities for Project PCAS such as but not limited to: Area mappings, Blender qualifications, Environmental qualifications in PKG, etc.

Bachelor of Science, 5 years or more of experience performing investigations, CAPA’s and SOP’s in the pharmaceutical industry.

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.

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).

• 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.

• 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.

Doctorate degree in Sciences or Master’s degree in Sciences and 3 years of directly related experience or Bachelor’s degree in Sciences and 5 years of directly related experience
Experience conducting GMP investigations and writing technical documents in English. Preferably, supplier related investigations. Highly organized person to ensure meeting timelines with minimum supervision.

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. ollaborate 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.

Qualifications:
Bachelor’s degree in engineering, computer science or related field. 5 years Experience with validating Laboratory equipment such as HPLC, IR, Titrators, and/or others. Knowledge of OMNIC, TIAMO, Empower and LIMS a plus. Ideal candidate has a combination of good CVS experience, technical writing, lab setting, and Project management skills.

Responsibilities:
SME for Generation and execution of CVS protocols. Average day consists of Writing protocols for CVS related to lab equipment, Executing protocol, Writing summary boards, Follow up with appropriate approval process, Provide site/lab updates to management, Provide expertise in data integrity/CVS.

Estamos identificando recursos para cubrir unas oportunidades de Delineante.

• Debe poseer licencia de conducir vigente, certificado de antecedentes penales actualizado.
• Responsable, organizado y con mucha iniciativa.
• De 4 a 5 años de experiencia en la industria farmacéutica.
• Debe tener alto conocimiento en AutoCAD.