Related skills
validation process validation risk assessment cgmp 21 cfr part 11📋 Description
- Lead validation lifecycle for processes, equipment, utilities
- Author/review OQ/PQ protocols for complex systems
- Act as Validation SME for equipment, systems, processes
- Drive VVP activities for new product introductions and tech transfers
- Develop MVP-aligned validation strategies (ASTM E2500, lifecycle)
- Lead ES studies and data analysis to support validation decisions
🎯 Requirements
- Bachelor’s degree and 7+ years in validation or quality engineering
- Strong knowledge of 21 CFR Parts 210, 211, and 11
- Experience leading validation for manufacturing equipment, systems, and processes
- Proficient in validation documentation, lifecycle validation, risk assessment
- Leadership and cross-functional collaboration skills
- Willingness for off-shift/weekend work and occasional travel
🎁 Benefits
- Flexible PTO, holidays, and parental leave
- Generous healthcare benefits, HSA match, 401k match
- Employer-paid life and disability insurance
- Pet insurance and wellness discounts
- Training and career development opportunities
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