Validation Engineer I

Pfizer Venezuela S.A

Base: $68,600.00 - $114,300.00; bonus/equity: 7.5%...
Hybrid
Cgmp production
Clinical drug substance
Validation support
This role will provide validation support related to qualification of manufacturing processes and equipment used for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio

Job Summary

  • This role will provide validation support related to qualification of manufacturing processes and equipment used for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.
  • As part of the Clinical Manufacturing Validation team, you will support GMP‑compliant validation activities for clinical manufacturing operations.
  • We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.

Matching Summary

This role will provide validation support related to qualification of manufacturing processes and equipment used for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.

Salary

Base: $68,600.00 - $114,300.00; Bonus/Equity: 7.5% bonus target; Benefits: 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage

Skills & Requirements

Must-have

  • cGMP production
  • clinical drug substance
  • validation support
  • manufacturing processes and equipment
  • cleaning validation
  • equipment changeover
  • chamber qualification
  • sterilization qualification
  • steam quality testing
  • temperature mapping
  • periodic review
  • GMP-compliant validation activities
  • IQ/OQ/PQ activities
  • validation documentation review
  • process and equipment understanding
  • compliance requirements
  • safe work environment
  • bench scale cleaning studies
  • carryover limits and HBELs

Nice-to-have

  • continuous improvement mindset
  • operational excellence
  • problem solving
  • enhance productivity
  • team member in a matrix development team
  • continuous improvement

Key Requirements

  • Bachelor's degree with 0+ years experience
  • Associate's degree with 4 years experience
  • High school diploma with 6 years experience
  • GMP biotechnology manufacturing or laboratory environment
  • execute against Standard Operating Procedures
  • document entries in a compliant manner
  • Strong analytical and computer skills
  • Excellent oral and written communication skills
  • maintain a safe work environment
  • facility/equipment commissioning and qualification
  • creating essential cGMP documentation
  • using common AI tools

Work Rights

Permanent work authorization in the United States

Tailored Resume

Cover Letter