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validation quality engineering iq/oq/pq 21 cfr part 11 change control📋 Description
- Lead validation lifecycle for processes, equipment, and utilities in cGMP.
- SME for validation of equipment, systems, and manufacturing processes.
- Drive VVP for new products, tech transfers, and readiness.
- Develop MVP-aligned validation strategies and lifecycle plans.
- Lead Engineering Studies, process characterization, and data analysis for validation.
- Mentor Validation Engineers I/II; support audits and documentation quality.
🎯 Requirements
- Bachelor's degree in Engineering, Life Sciences, or related discipline.
- 7+ years in validation, quality engineering, or technical services (cGMP).
- Strong knowledge of 21 CFR Parts 210, 211, and 21 CFR Part 11.
- Led validation projects for manufacturing equipment, systems, and processes.
- Proficient in lifecycle validation, risk assessment, and documentation practices.
- Leadership and cross-functional collaboration; ability to manage multiple projects.
🎁 Benefits
- Flexible PTO, holidays, and parental leave.
- Generous healthcare benefits, HSA match, 401k match, life and disability insurance, pet insurance, wellness discounts.
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