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Pfizer Process Scientist/Engineer 1 in Andover, Massachusetts

ROLE SUMMARY

The engineer/ scientist in manufacturing operations is responsible for execution of the manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development drug substance. Additional roles include using operational and technical knowledge to assist in troubleshooting activities, tech transfer and start-up activities, provide investigations support, analyze process data, and identify and implement minor process improvements.

ROLE RESPONSIBILITIES

• Execution of relevant process activities including protein purification or cell culture operations (depending on the background of the candidate), solution formulation, and equipment preparation (set-up, CIP, SIP) by following established SOP's.

• Setup and evaluation of unit operations, execution, and changeover (daily and long-term).

• Troubleshooting of mildly complex process disturbances, identifying resolution and implementing corrective and preventive measures, as required.

• Real time assessment of process performance.

• Individual will be required to perform process monitoring and data analysis, and data preparation for presentation in several forums including project team meetings.

• Serve as the operations point of contact for technology transfer and start-up of products by reviewing process parameter tables and applicable documentation.

• Provide input for process overview presentations, sampling plans, and other tech transfer deliverables.

• Individual will provide subject matter expertise in supporting process and product related investigations, execute CAPAs and provide input to process and equipment change controls to ensure robust and capable solution.

• Individual will help to ensure the equipment and facilities are maintained in a GMP compliant state at all times.

• The individual will be responsible for collaborating within the department as well as other departments to communicate and coordinate activities.

• Individual will assist in inventorying, tracking, maintenance scheduling, and troubleshooting of mechanical equipment.

• Individual will be responsible for modifying and/or creating job related documentation

• Individual will assist in the evaluation and implementation of new technology for process execution or analysis.

• Individual will be expected to participate in continuous improvement and innovation initiatives.

• Individuals are responsible to ensure a safe work environment and to identify job hazard analysis opportunities.

• Individuals will be required to develop multi-tasking skills.

• Identifies the need for escalation through various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance.

QUALIFICATIONS

• BS in Life Sciences.

• MS in life Science

• Experience in a GMP manufacturing environment is desired.

PREFERRED QUALIFICATION

• Experience with either purification processes or cell culture.

• Supports operations (such as solution preparation and/or operation of autoclave/depyrogenation ovens) is not essential but is highly desirable.

• The ability to execute against SOP's and document entries in a cGMP compliant manner.

• Ability to interpret and prioritize workflow to maintain the production schedule.

• Effective verbal and written communication skills.

• Leads continues improvement and root cause analysis activities (M1 methodology, 5S, DMAIC, LEAN tools etc.)

  • Last Date to Apply for Job: 5.28.2020

  • Eligible for Employee Referral Bonus

  • #LI-PFE

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Manufacturing

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