Lead CQV Engineer

Katalyst CRO; Tulsa (OK); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO in Tulsa, OK is seeking a seasoned CQV professional to lead the second shift validation activities across multiple systems. The role requires coordinating daily priorities to recover schedule slippage while maintaining timelines and interfaces with QA, Engineering, and Operations to resolve issues in real time.

You will oversee IQ/OQ execution, support temperature mapping, MOC, weld verifications, SIP/CIP cycle development, and ensure all documentation meets GMP/GDP and audit

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.

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

Shift leadership

GMP/GDP knowledge

Pharma validation

Process equipment

eVal experience

Education

Bachelor's degree in STEM

STEM degree preferred

Tools

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.
• 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.

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.
• 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.

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).