Lead CQV Engineer

Katalyst CRO; Concord (NH); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO in Concord, NH is seeking an experienced CQV professional to lead second shift validation activities across multiple systems and workstreams.

You will coordinate execution priorities, interface with QA, Engineering, and Operations, and drive IQ/OQ verification, walkdowns, and documentation to audit-ready standards. 8+ years in pharma/biotech CQV with GMP/GDP expertise and experience managing shift-based teams are required.

Qualifications

• 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.

Responsibilities

• 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
• 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

Skills

CQV execution

Leadership

GMP/GDP knowledge

Temperature mapping

Education

Bachelor’s degree in STEM

Biomedical/ Chemical Engineering preferred

Tools

eVal

ValGenesis

Ellab

Job description

Responsibilities

• 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
• 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