Lead CQV Engineer

Katalyst CRO; Memphis (TN); On-site; USD 90,000 - 150,000; Full time

Job summary

Katalyst CRO in Memphis, TN seeks a senior CQV lead to drive second‑shift validation activities across multiple systems and workstreams. You will coordinate daily execution priorities to recover schedule slippage and maintain timelines while interfacing with QA, engineering, and operations to resolve issues in real time.

You will oversee IQ/OQ protocols and operational verification activities, drive deviation identification and escalation, and ensure GMP/GDP compliance and audit readiness.

Qualifications

• Bachelor's degree or equivalent required in a STEM field.
• 8+ years of CQV/validation experience in pharma or biotech.
• Hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF).
• Proven experience leading validation teams or shift-based execution efforts.
• GMP/GDP knowledge required; familiarity with GMP audit readiness.

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.
• Drive deviation identification, escalation, and resolution; ensure documentation meets GMP/GDP.

Skills

CQV/validation

Shift leadership

GMP/GDP

Process equipment

Issue resolution

Education

Bachelor's Degree or equivalent

STEM degree

Biomedical Engineering

Chemical Engineering

Tools

eVal

ValGenesis

Ellab

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.

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.

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.

Support and review

• 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.