Principal QA Validation Specialist (Fill Finish)

Principal QA Validation Specialist — Quality Assurance

Responsibilities:
- Lead validation and serve as SME for utilities and environmental qualification; assess change controls, review CAPAs/NOEs, approve documents, and lead audits
- Plan and execute cleanroom qualifications and requalification; oversee EMPQ for filling line clean air equipment
- Drive QRM deliverables including HACCP assessments and continuous trending/reporting
- Lead investigations of contamination events tied to environmental monitoring in cleanrooms and clean air equipment
- Qualify critical utilities: WFI, pharmaceutical air, AHUs, clean steam generators, and nitrogen distribution systems
- Manage and develop a specialist and a team of consultants to meet project milestones and deliver qualification/documentation deliverables
- Establish processes to ensure regulatory compliance, including participation in Annex 1 gap assessments
- Influence creation/revision of local/global policies, standards, procedures, and business processes

“Role Might Be For You If You” / Qualifications:
- Demonstrated experience in a cGMP-regulated environment (validation, inspection, audit readiness)
- Strong cross-functional collaboration and communication skills
- Ability to lead teams in a fast-paced environment
- Able to gown and work in manufacturing areas as required

Education & Required Experience:
- BS/BA in Engineering, Chemistry, or Life Sciences
- 8+ years of relevant experience
- Experience in utility and facility qualification/validation is required

Application / Work Schedule:
- Work Monday–Friday, 8am–4:30pm

Gowning & Environment:
- Full cleanroom attire; remove jewelry/makeup/nail adornments
- Use sanitizing agents during gowning (including IPA)

Benefits (if explicitly stated):
- Salary range: $92,200.00 - $150,600.00 (annually)

How to Apply:
- Apply now