Senior Validation Engineer (Life Sciences)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Senior Validation Engineer (Life Sciences): Overseeing technical compliance and ensuring the integrity of manufacturing equipment and processes with an accent on IQ/OQ/PQ protocols and GxP regulatory standards. Focus on leading complex deviation investigations, managing change control, and maintaining inspection readiness.
Location: Onsite in Rensselaer, NY, USA
Salary: $108,200 – $162,200
Company
is a professional staffing agency specializing in technical and scientific placements.
What you will do
- Lead the review and approval of Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocols and generate final reports.
- Evaluate and approve Change Requests to ensure equipment and systems remain in a validated state.
- Audit SOPs and technical documents to ensure continuous adherence to regulatory standards.
- Conduct root cause analysis and lead deviation investigations for validation failures.
- Represent the validation department during internal and external regulatory inspections.
- Manage the Annual Product Review (APR) process through cross-functional coordination.
Requirements
- Bachelor’s degree in Chemistry, Engineering, or a related technical field with 8+ years of experience (or Master's + 6 years / PhD + 4 years).
- Must be based in or able to work onsite in Rensselaer, NY.
- Expertise in root cause analysis and professional technical writing.
- Strong understanding of regulatory requirements within a GxP environment.
- Commitment to workplace safety and rigorous technical standards.
Culture & Benefits
- Major medical, dental, and vision insurance for assignments lasting 13+ weeks.
- 401k retirement plan.
- Statutory sick pay where required.
- Equal Opportunity Employer committed to reasonable accommodations for disabilities.
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