Katalyst CRO · 4 hours ago
Lead Validation Engineer
St Louis, MO
Contract
Onsite
Senior Level, Lead/Staff
7+ years expKatalyst CRO is a company specializing in GMP equipment installation and qualification for biologics manufacturing. The Lead Validation Engineer will oversee projects ensuring compliance with regulatory standards and lead cross-functional teams to achieve project goals.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead end-to-end CQV execution for GMP equipment projects, managing activities from installation through IQ, OQ, and PQ for biologics manufacturing systems including bioreactors, media/buffer preparation, chromatography, filtration, and associated utilities
Drive project planning and execution, developing and maintaining integrated schedules, budgets, and resource plans while proactively identifying risks and implementing mitigation strategies to support on-time, compliant delivery
Coordinate and direct cross-functional teams (Engineering, Manufacturing, MSAT, Quality, Validation, Automation, and vendors) to ensure alignment on technical requirements, execution strategy, and readiness for qualification milestones
Ensure full regulatory and quality compliance, including adherence to cGMP, biosafety requirements, and site quality systems; review and approve URSs, FAT/SAT documentation, installation packages, and qualification protocols
Serve as the primary technical and communication lead for equipment CQV activities, providing regular status updates to stakeholders and supporting change controls, deviations, and CAPAs related to equipment implementation and qualification
Lead CQV activities for facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI (reverse osmosis deionized) water skid upgrades, parts washer upgrades, and installation and qualification of autoclaves
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related technical field
7+ years of progressive experience in Commissioning, Qualification, and Validation (CQV) within GMP-regulated pharmaceutical or biotechnology manufacturing environments
Demonstrated experience leading GMP equipment and utility projects from installation through IQ, OQ, and PQ, supporting biologics manufacturing processes such as CHO cell culture, media/buffer preparation, chromatography, filtration, and clean utilities
Strong working knowledge of cGMP regulations, biosafety requirements, and site quality systems, with experience supporting regulatory inspections and audit readiness
Proven ability to lead cross-functional teams and vendor partners, manage project schedules and budgets, and communicate technical status, risks, and mitigation plans to stakeholders
Hands-on experience reviewing and approving URSs, FAT/SAT documentation, installation packages, qualification protocols, and supporting change controls, deviations, and CAPAs
Preferred
advanced degree or relevant certifications (e.g., CQV, PMP)
Preferred experience supporting facility and utility upgrade projects, including AHU replacements, boiler replacements, generator improvements, clean steam generator replacements, RODI water skid upgrades, parts washer upgrades, and installation/qualification of autoclaves
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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