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Sr Validation Specialist
New York, NYApril 5th, 2026
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 consultant will also support change controls, deviation investigations, and continuous improvement efforts while ensuring alignment with internal quality systems and regulatory expectations.Prior experience working with validation and asset management platforms such as Veeva, Blue Mountain RAM, or Maximo is considered a strong plus.This role requires a highly collaborative professional who can partner cross-functionally with quality, engineering, and manufacturing teams to maintain a compliant and inspection-ready environment.NOTE: Flexibility to work first and second shift. Some Saturdays. ... required.
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