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Sr. Associate Engineer, Clinical Manufacturing

Employer
Pfizer
Location
Andover, Massachusetts
Salary
Competitive
Closing date
Jan 15, 2022

View more

Discipline
Physical Sciences, Engineering, Other, Manufacturing/QA/QC
Position Type
Full Time
Organization Type
Pharma
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Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

Sr. Associate Engineer, Clinical Manufacturing is part of a multi-disciplinary team responsible for cGMP production of clinical drug substance supporting the Pfizer Biotherapeutics portfolio.

At Pfizer, we innovate every day to make the world a healthier place. It was the vision of Pfizer at the very beginning and it holds true today in everything we do. From scientific discovery to breakthrough products to our essential partnerships around the world, we're committed to quality healthcare for everyone. Because every individual matters. Our medicines and vaccines save or improve countless lives and our consumer products empower people to take care of themselves. Pfizer Corporate Responsibility believes that all individuals, everywhere, deserve access to quality healthcare and the opportunity to lead healthy lives.

Sr. Associate Engineer, Clinical Manufacturing functions as part of a multi-disciplinary team responsible for delivery of cGMP phase I/II clinical drug substance supporting the Pfizer Biotherapeutics R&D portfolio. The focus includes providing direct manufacturing support and hands-on involvement in upstream and downstream processing, qualification of equipment and processes, contributing to continuous improvement, particularly in cGMP procedures, and the design and procurement of processing aids and equipment, and training of operations colleagues. Support functions may include owning and leading deviation and investigations, CAPA implementation, operational and continuous improvement projects, and development and mentoring of junior colleagues.

Diversity, equality and inclusion are an integral component of Pfizer's mission to build a vibrant culture. We maintain the highest standards of ethics and compliance in all of our business practices.

How You Will Achieve
  • Execute and troubleshoot all unit operations associated with microbial and mammalian processing including upstream / fermentation and purification / separation processes in a cGMP environment. Includes support and troubleshooting of CIP and changeover operations.
  • Lead or contribute to tech transfer activities for new products and product changeover
  • Authorship of and execution against SOP's for facility and process 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 and junior colleagues
  • Lead/support implementation of new technologies and equipment
  • Lead/support investigations and audits as needed


Qualifications

Must-Have
  • BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent
  • 3+ years of experience in a laboratory or manufacturing environment


Nice-to-Have
  • Prior experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting
  • Knowledge of harvest, chromatography and filtration processes
  • Experience with operation of flexible and 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 25 lbs
  • Ability to thrive in dynamic team environment with diverse perspectives
  • Propensity for creative problem solving and courage to share and actively promote innovative ideas of self and others.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Ability to work off shift (Nights and Weekends) as needed; non-routine
  • Ability to work in a clean room environment.


Other Job Details:
  • Last Date to Apply for Job: January 26th, 2022


#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Research and Development

#LI-PFE
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