Associate Engineer, Clinical Drug Substance

Employer
Pfizer
Location
Andover, Massachusetts
Posted
Sep 24, 2021
Ref
4825451
Required Education
Bachelors Degree
Position Type
Full time
Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

You will be part of a multi-disciplinary team responsible for cGMP (current Good Manufacturing Practices) production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. Your 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. After the start of the facility, you will transition to a team that will be responsible for the execution of microbial upstream and downstream processes.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

 It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Support completion of Good Manufacturing Practices {also cGMP} documentation.
  • Execute and troubleshoot downstream mammalian and microbial purification processes in a cGMP {part of GxP} environment.
  • Support tech transfer activities for new products and product changeover for operations team.
  • Identify and support the resolution of quality concerns and contribute to the subsequent investigational reports within the quality system.
  • Make recommendations for continuous improvement opportunities with regard to safety, quality, and efficiency.
  • Assist with associated tooling, change parts and perform in-process operational checks associated with clinical manufacturing.
  • Work in electronic systems including QMS, Documentation, Laboratory Information Management System Enterprise Resource Planning (e.g.: SAP) etc.
  • Understand data integrity principles and application within systems.
  • Work on supporting and troubleshooting of process equipment and Clean-in-place (CIP) and Steam-in-place (SIP) operations.
QualificationsMust-Have
  • Bachelor's Degree
  • Experience with Tech Transfer, Facility Fit assessments and engineering design
  • Demonstrated experience in a biotechnology manufacturing or laboratory environment
  • Ability to execute against Standard Operating Procedures and document entries in a compliant manner
  • Demonstrated capability to work as a team member in a matrix development team.
  • Maintains a safe work environment
  • Excellent oral and written communication skills
  • Strong analytical and computer skills
Nice-to-Have
  • Prior experience in a Biological Pilot Plant or Commercial Manufacturing setting
  

PHYSICAL/MENTAL REQUIREMENTS

  • Must be able to climb flights of stairs, and remain standing for extended periods of time.
  • Must be able to lift up to 50 lbs
  • Ability to thrive in dynamic team environment with diverse perspectives


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • This is a 2nd shift position, however during commissioning and start up, the candidate may work 1st shift hours.
  • Ability to work nights and weekends as needed depending upon process needs; non-routine.

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.

Manufacturing

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