Process Scientist / Engineer I

Pfizer Andover , MA 01810

Posted 1 week ago

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, 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 and/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.

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, 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 and/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.

BASIC QUALIFICATIONS

  • With Engineering Degree
  • A minimum of a BS in Engineering
  • MS (unrelated)
  • Without Engineering Degree
  • BS in Life Sciences .
  • MS (related)
  • Experience in a biopharmaceutical environment is preferred.

PREFERRED QUALIFICATIONS

  • Experience in a biopharmaceutical environment

  • Last Date to Apply for Job: 03.31.2020

  • Eligible for Employee Referral Bonus

  • #LI-PFE

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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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Process Scientist / Engineer I

Pfizer