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Lead CQV Engineer

Katalyst Healthcares and LifesciencesConcord, NH🇺🇸United StatesPosted 14 Aug 2026

Quick Overview

Work Type
Hybrid
Level
Mid Senior

Job Description

Job Description:
  • Lead second shift CQV execution activities across multiple systems and workstreams
  • Coordinate daily execution priorities to recover schedule slippage and maintain timelines
  • Interface with QA, Engineering, and Operations to resolve issues in real time
  • Oversee execution of IQ/OQ protocols and operational verification activities

Responsibilities:
  • Drawing walkdowns
  • Equipment and component verification
  • Materials of Construction (MOC) and weld verification
  • Provide oversight for temperature mapping and validation activities
  • Support SIP/CIP and related cycle development activities as needed
  • Ensure all documentation meets GMP/GDP and audit-ready standards
  • Drive deviation identification, escalation, and resolution

Requirements:
  • Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
  • 8+ years of CQV/validation experience in pharma or biotech
  • Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF)
  • Proven experience leading validation teams or shift-based execution efforts
  • Strong GMP/GDP knowledge
  • Experience with eVal (required), ValGenesis a plus
  • Experience with temperature mapping (Ellab a plus)
  • This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

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