Pfizer Associate Engineer, Clinical Manufacturing in Andover, Massachusetts

ROLE SUMMARY

The clinical manufacturing operations engineer is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.

Initial focus is on the start-up of a new facility in support of facility/equipment commissioning and qualification, creation of necessary cGMP documentation, and training of operations staff.

Post facility start up, the successful candidate will transition to 2nd shift to be part of a team that will be responsible for the execution of upstream mammalian and microbial processes.

ROLE RESPONSIBILITIES

  • Execute and troubleshoot upstream mammalian cell culture and microbial fermentation processes in a cGMP environment. Includes support and troubleshooting of CIP, SIP operations.

  • Lead/support tech transfer activities for new products and product changeover for operations team

  • Authorship of and execution against SOP's for upstream unit operations

  • Lead/support the creation of manufacturing batch records and other cGMP documentation

  • Data analysis and communication/collaboration with tech transfer team, development labs and quality

  • Training of operations colleagues

  • Support implementation of new technologies and equipment

  • Support investigations and audits as needed

BASIC QUALIFICATIONS

  • BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent

  • 0-2 years of experience in a laboratory or manufacturing environment

PREFERRED QUALIFICATIONS

  • Knowledge of mammalian cell culture and/or microbial fermentation processes

  • Experience with operation of single use systems.

  • Experience with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS, Microsoft Word, Excel, etc.)

  • Ability to execute against SOP's and document entries in a compliant manner

  • Demonstrated capability to work as a team member in a matrix manufacturing team

  • Excellent oral and written communication skills

  • Ability to work under minimal supervision

PHYSICAL/MENTAL REQUIREMENTS

  • Must be able to climb flights of stairs, and remain standing for 1-2 hours

  • Must be able to lift up to 50 lbs

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • This is a 2nd shift position, however during commissioning and start up, the candidate will work 1st shift hours. Once the facility is operational, the candidate will transition to 2nd shift.

  • Ability to work off shift (Nights and Weekends) as needed; non-routine

  • Ability to work in a clean room environment

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.

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.

Other Job Details:

  • Last Date to Apply for Job: July 1, 2018

  • Eligible for Employee Referral Bonus: yes

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.