Validation Engineer Iii

AGC Biologics

Bothell, WA, US
Base: $94,000 - $129,250; bonus/equity: not specif...
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Cgmp manufacturing validation experience
Iq oq pq protocol execution
Facility and utility qualification
** AGC Biologics is seeking a Validation Engineer III to ensure compliance and quality in their cGMP manufacturing processes. The role requires extensive experience in validation within a regulated environment and offers the opportunity to collaborate across teams to drive continuous improvement. **

Job Summary

  • The role involves qualifying and validating facilities, utilities, equipment, and computerized systems that power cGMP manufacturing of protein-based therapeutics.
  • Candidates will prepare and execute IQ/OQ/PQ protocols while managing requalification activities in support of change controls.
  • AGC Biologics is a global CDMO committed to delivering life-changing therapies with a culture defined by Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork.

Matching Summary

Match Score: 75

** AGC Biologics is seeking a Validation Engineer III to ensure compliance and quality in their cGMP manufacturing processes. The role requires extensive experience in validation within a regulated environment and offers the opportunity to collaborate across teams to drive continuous improvement. **

Salary

Base: $94,000 - $129,250; Bonus/Equity: Not specified; Benefits: Competitive package described

Skills & Requirements

Must-have

  • cGMP manufacturing validation experience
  • IQ OQ PQ protocol execution
  • Facility and utility qualification
  • Computerized system validation
  • Change control and CAPA management

Nice-to-have

  • Cross-functional collaboration skills
  • Continuous improvement mindset
  • Technical problem-solving abilities
  • Regulatory inspection support experience

Key Requirements

  • Bachelor's degree with 8+ years validation experience
  • Master's degree with 6+ years validation experience
  • Experience in cGMP environment
  • Knowledge of GMP, ICH, and ISO requirements

Work Rights

Not specified

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