Lead CQV Engineer

Katalyst CRO; Concord (NH); On-site; USD 110,000 - 160,000; Full time

Job summary

Katalyst CRO seeks a CQV/validation expert for second shift in a pharma/biotech environment. Lead CQV execution across multiple systems, coordinate priorities to recover schedule slippage, and interface with QA, Engineering, and Operations to resolve issues in real time.

Must have 8+ years of CQV/validation experience, strong GMP/GDP knowledge, and hands-on experience with bioprocess equipment. Second shift (2-10 PM EST) and weekend work required.

Qualifications

• Bachelor's degree required; STEM preferred.
• 8+ years CQV/validation experience in pharma/biotech.
• Strong hands-on execution background with process equipment.

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.

Skills

CQV/validation

GMP/GDP knowledge

Leadership

Documentation

Deviation management

Regulatory compliance

Equipment validation

Education

Bachelor's Degree in STEM

Tools

eVal

ValGenesis

Ellab

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

• 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