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validation 21 cfr part 11 installation qualification operational qualification astm e2500📋 Description
- Lead validation lifecycle for processes, equipment, utilities, and studies.
- Act as Validation SME guiding Engineering, Manufacturing, Automation, and QA.
- Develop strategies aligned with MVP, ASTM E2500, and lifecycle validation.
- Drive on-time validation for new products, tech transfers, and launches.
- Mentor Validation Engineers and help define site validation standards.
- Collaborate cross-functionally to support quality and regulatory goals.
🎯 Requirements
- Bachelor's degree in Engineering, Life Sciences, or related.
- 7+ years in validation/quality engineering within a cGMP environment.
- Strong knowledge of 21 CFR Parts 210, 211, and 21 CFR Part 11.
- Led validation projects for manufacturing equipment, systems, and processes.
- Advanced proficiency in validation documentation, lifecycle validation, and risk management.
- Experience with automation and control systems; FAT oversight.
🎁 Benefits
- Competitive compensation including base salary and annual bonus.
- Flexible PTO, holidays, and parental leave.
- Healthcare benefits, HSA match, 401k match, life/disability insurance.
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