Validation Engineer Ii

American Regent Inc

Cgmp regulations knowledge
Validation protocol development
Equipment qualification experience
The Validation Engineer II will develop and execute validation plans, protocols, and reports that support the business needs of the company

Job Summary

  • The Validation Engineer II will develop and execute validation plans, protocols, and reports that support the business needs of the company.
  • This position serves as a Subject Matter Expert focusing on Packaging, Equipment, Facilities, and Cleaning Validation for aseptic parenteral pharmaceuticals.
  • The incumbent must maintain life cycle documentation and ensure all work is performed in accordance with cGMP and health and safety requirements.

Matching Summary

The Validation Engineer II will develop and execute validation plans, protocols, and reports that support the business needs of the company.

Skills & Requirements

Must-have

  • cGMP regulations knowledge
  • validation protocol development
  • equipment qualification experience
  • aseptic manufacturing processes
  • technical writing skills
  • cleanroom gowning capability

Nice-to-have

  • mentoring junior team members
  • independent decision making
  • cross-functional collaboration
  • troubleshooting manufacturing anomalies

Key Requirements

  • Bachelor's Degree in Life Sciences or Engineering
  • 3 years of validation experience in Pharmaceutical industry
  • Strong knowledge of cGMP regulations
  • Ability to read engineering drawings

Work Rights

Not specified

Tailored Resume

Cover Letter