Lead CQV Engineer/Validation Engineer
Lead CQV Engineer / Lead Validation Engineer
Location: St. Louis, MO
Employment Type: Full-Time, On-Site
Industry: Biotech / Pharma (Biologics Manufacturing)
Salary Range: ~$90,000 - $130,000 base (dependent on experience)
Role Overview
A leading life sciences consulting organization is seeking a Lead CQV Engineer / Lead Validation Engineer to support large‑molecule biologics manufacturing at a GMP-regulated site. This is a hands-on, project‑owning CQV role, responsible for end‑to‑end commissioning, qualification, and validation of GMP equipment, facilities, and utilities.
This position is not a QA role and not documentation‑only. The ideal candidate will lead CQV execution from equipment installation through IQ, OQ, and PQ, working cross‑functionally with Engineering, Manufacturing, Automation, MSAT, and Quality.
Key Responsibilities
- Lead end‑to‑end CQV activities for GMP equipment and systems, managing execution from installation through IQ, OQ, and PQ
- Support upstream and downstream biologics manufacturing processes including bioreactors, media and buffer prep, chromatography, filtration, and associated utilities
- Serve as CQV system owner for multiple projects, providing technical leadership and execution ownership
- Develop, review, and approve validation documentation including URSs, FAT/SAT protocols, installation packages, and IQ/OQ/PQ protocols
- Drive project planning and execution, including schedules, resource coordination, risk identification, and mitigation
- Coordinate closely with cross‑functional stakeholders including Engineering, Automation, Manufacturing, MSAT, Quality, and external vendors
- Support facility and utility qualification activities such as clean steam, RODI/WFI systems, HVAC/AHUs, boilers, generators, autoclaves, and parts washers
- Participate in change controls, deviations, and CAPAs related to equipment implementation and validation
- Support inspection readiness and regulatory interactions related to CQV activities
Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related technical field
- 7+ years of CQV or validation experience in GMP pharmaceutical or biotech manufacturing environments
- Strong experience leading CQV activities for biologics or large‑molecule manufacturing
- Demonstrated ownership of IQ, OQ, and PQ execution (not execution‑only support)
- Hands‑on experience qualifying GMP process equipment and utilities
- Solid understanding of cGMP requirements and validation lifecycle best practices
- Experience working with automated or PLC‑controlled systems, including alarm testing and interlocks
- Proven ability to lead cross‑functional teams and manage multiple stakeholders
- Comfortable working fully onsite in a manufacturing environment
Compensation & Benefits
- Competitive base salary range of ~$90,000-$130,000 depending on experience
- Comprehensive benefits package including medical, dental, vision, 401(k) with employer match, PTO, and paid holidays
- Exposure to complex biologics systems, utilities, and capital projects
- Opportunity to take on broader technical ownership than typical in‑house validation roles
Ideal Candidate Profile
- 7-12 years of CQV experience
- Strong equipment and utilities background
- Comfortable leading CQV strategy and execution
- Experience in consulting, CDMO, or large pharma environments
FAQs
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