Associate Engineer, Clinical Manufacturing

Employer
Pfizer
Location
Andover, Massachusetts
Posted
Jul 02, 2022
Ref
4847140
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 primarily clinical drug substance supporting the Pfizer Biotherapeutics portfolio. You, along with your teammates, will be responsible for the execution of upstream and downstream processes.

As an associate engineer, your focus is on the process from a technical perspective with a hands-on approach. 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 mammalian and microbial upstream and downstream processes in a cGMP {part of GxP} environment.

  • Support Tech Transfer activities for new products and Product Changeover (PCO) activities.

  • Identify and support the resolution of quality concerns and contribute or own 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 and practice data integrity principles and application within systems.

  • Work on supporting and troubleshooting of process equipment.

QualificationsMust-Have
  • Bachelor's Degree

  • < 2 years of direct experience with at least one of the following areas: bioprocess cell culture, fermentation, purification, GMP manufacturing, Tech Transfer, Facility Fit assessments or engineering design.

  • Ability to execute against and write Standard Operating Procedures and Manufacturing Batch Records and document entries in a compliant manner.

  • Demonstrated capability to work as a team member in a highly dynamic environment.

  • Maintains a safe work environment

  • Excellent oral and written communication skills

  • Strong analytical and computer skills.

Nice-to-Have
  • 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.

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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