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🥝 Sr Validation Specialist
Katalyst Healthcares & Life Sciences | New York County, New York, United States | Posted May 16, 2026
Job Description
Job Description:
- Our client is seeking an experienced Senior Validation Consultant to support critical quality and compliance initiatives within their manufacturing operations.
- This consultant will play a key role in validation and quality oversight across sterile and packaging processes, with a particular focus on visual inspection, parenteral syringes, and packaging operations.
- The ideal candidate will bring deep expertise in data integrity and 21 CFR Part 11 compliance, along with hands-on experience performing critical assessments, validation strategy development, and risk management activities to ensure regulatory readiness and operational excellence.
Responsibilities:
- Reviewing and revising SOPs, executing and overseeing CQV activities, and supporting validation lifecycle deliverables including IQ, OQ, and PQ.
- The c...