07 Oct, 2021

Principal Process Engineer/Scientist

  • Pfizer
  • Andover, MA, USA
Process Engineer Biochemicals / Pharmaceuticals

Job Description

ROLE SUMMARY

The Andover Site Technical Services Group (ASTS) is seeking a highly motivated individual for a Principal Process Scientist/Engineer.  The ideal candidate will have hands on leadership experience with large scale biopharmaceutical processes/equipment principles and practices.  A strong regulatory compliance and Good Manufacturing Practice mindset/experience is highly required.
 

The role encompasses the ongoing lifecycle process/product management of commercial and near-commercial biopharmaceuticals drug substances compounds including development and implementation of regulatory post approval process changes.    The individual will be expected to provide detailed technical leadership, process understanding and expertise in support of processes within all manufacturing suites at the Andover, MA manufacturing site including both mammalian and bacterial processes.  A track record of solving complex technical, regulatory, compliance and operational issues through collaboration with stakeholders and other scientists, engineers, operations, and quality control/quality assurance groups.  Familiarity with Lean/Six-Sigma methodologies is desirable.

 

ROLE RESPONSIBILITIES

  • Ownership of the lifecycle management of two or more biopharmaceutical commercial products
  • Collation, analysis and communication of process performance for the purpose of educating staff and developing ideas for process improvement/robustness.
  • Lead (or be an active participant) in cross functional teams in the evaluation, regulatory assessment and implementation of process improvements, process changes and new manufacturing technologies
  • Provide technical process expertise in evaluation of process and regulatory trends/requirements and subsequent implementation of associated changes.
  • Provide technical process expertise in determination of root cause of process excursions and drive implementation of corrective actions. 
  • Assist in planning for and management of production campaigns
  • Assess changes to raw materials and their impact on the process (s).
  • Take on projects in support of operational/process robustness across multiple products and manufacturing suites
  • Be responsible for or assist with regulatory filings and regulatory query responses under critical timelines.
  • Be the technical lead in representing a process/product during internal audits and board of health inspections

 

Role Success Factors

  • Ability to work and collaborate on multi-functional teams
  • Ability to interpret and communicate complex technical and process information/issues concisely to facilitate decision making
  • Project management capability
  • Self-motivated and able to drive multiple assignments simultaneously.
  • Able to adapt to changing priorities as business needs demand

 

MINIMUM QUALIFICATIONS

  • Minimum BS + 10 or MS + 8 years experience in science or engineering working in a pharmaceutical or biopharmaceutical environment.  

 

PREFERRED QUALIFICATIONS

  • BS + 12 or MS +10 years experience in science or engineering working in pharmaceutical or BioPharmaceutical environment

 

PHYSICAL/MENTAL REQUIREMENTS

  • Perform complex data analysis for process analysis, troubleshooting or process improvement.  Thought leader regarding process robustness/process capability. 

 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Standard M-F on-site work week, days.  No or very limited travel required.

 

OTHER INFORMATION

  • Last date to apply: 10/15/21
  • Relocation eligible

 

 

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.


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