Verista · 6 hours ago
6153 - Lead CQV Engineer/ Lead Validation Engineer
St Louis, MO
Full-time
Onsite
Senior Level, Lead/Staff
$88K/yr - $132K/yr
7+ years expVerista is a company that collaborates with leading brands in the life science industry to address critical healthcare challenges. They are seeking a Lead Validation Engineer to oversee GMP equipment installation and qualification projects, ensuring compliance with regulatory requirements and effective project execution.
ComplianceHealth CareLife ScienceManufacturingPharmaceutical
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; advanced degree or relevant certifications (e.g., CQV, PMP) preferred
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
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
Benefits
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
Company
Verista
Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.
501-1000 employees
H1B Sponsorship
Verista 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 (7)
2024 (4)
2023 (13)
2022 (6)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Bill Murray
Chief Financial Officer
Dan White
Chief Operating Officer
Recent News
2023-12-22
2023-12-22
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