Pfizer Process Scientist/Engineer III in Andover, Massachusetts
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 lead troubleshooting activities, tech transfer and start-up activities, investigations, analyze process data, and identify and implement moderately complex process improvements.
Leading relevant process activities including protein purification and/or cell culture operations (depending on the background of the candidate), solution formulation, and equipment preparation (set-up, CIP, SIP) by following established SOPs.
Individual must be capable of acting as the shift manager in his/her absence.
Leading the setup and evaluation of unit operations, executions, and changeover (daily and long-term).
Troubleshooting of complex process disturbances, identifying resolutions, and implementing corrective and preventive measures, as required.
Real time assessment of process performance and predictive analysis with identification of course correction (if required).
Individual will be required to perform process monitoring, 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 approval of applicable documentation.
Generate process overview presentations, sampling plans, and other tech transfer deliverables (if required).
Should be capable of managing intra-departmental projects and performing relevant presentations with minimal supervision.
Individual will provide subject matter expertise in supporting process and author product related investigations, execute CAPAs, and provide impact assessment of complex process and equipment change controls to ensure a robust and capable solution with minimal supervision.
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 leading within the department as well as other departments to plan, communicate, and coordinate activities.
Individual will assist in leading the inventorying, tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
Individual will be responsible for authoring and/or approving job related documentation.
Individual will drive the evaluation and assist in the implementation of new technology for process execution or analysis.
Individual will be expected to participate and drive in continuous improvement and innovation initiatives. Individual is expected to be an M1 coach.
Individuals are responsible to ensure a safe work environment and to lead job hazard analysis and qualitative risk assessments.
Individuals will be required to develop the multi-tasking skills of peers.
Escalates and remediates with various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance.
Individual should be involved in mentoring junior level scientists/engineers.
With Engineering Degree
BS in Engineering 4+ years
MS (related) 2+ years
Without Engineering Degree
BS in Life Sciences with 6+ years.
MS (related) 4+ years
- Experience in a biopharmaceutical environment is preferred
Daily routine may require moving heavy equipment, standing for long periods of time, and/or significant walking throughout the suite including up and down stairs.
Requires the moving of heavy equipment and the ability to lift 50 pounds
The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam, and corrosive chemicals.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- 1st Shift, 6AM-6PM, rotating including weekends.
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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.
Last date to apply: 6/25/19
Eligible for Employee Referral Bonus
R (Rotating) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.