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Sr Validation Specialist

Company

Karwell Technologies

Location

New York County, New York, United States

Type

Full-time

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...

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