CQV/Project Manager

CQV/Project Manager - Biotech/Pharma IndustryLocation: Onsite - Los Angeles, CA surrounding areaJob Type: PermanentPlease note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.ADVENTs services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.This is an outstanding opportunity to join our growing team!About the RoleWe are seeking a highly experienced CQV (Commissioning, Qualification, and Validation) Project Manager to lead CQV efforts for biotech and pharmaceutical projects. This role is critical in ensuring that all equipment, systems, and processes meet regulatory and compliance standards. The ideal candidate will have 10+ years of CQV and project management experience within the Life Sciences industry.Key ResponsibilitiesProject Leadership - Manage end-to-end CQV activities for capital projects, from planning to execution.Regulatory Compliance - Ensure all CQV documentation aligns with FDA, cGMP, GAMP, and ISO standards.Risk & Quality Management - Develop and implement risk assessments and quality strategies.Stakeholder Coordination - Collaborate with engineering, quality, and regulatory teams to drive project success.Commissioning & Validation - Oversee equipment qualification (IQ/OQ/PQ) and validation of critical systems (HVAC, clean utilities, automation).Timeline & Budget Management - Track project deliverables, timelines, and budgets while ensuring efficiency.Process Optimization - Identify areas for improvement in CQV strategies and execute solutions.Required QualificationsBachelor's/Master's in Engineering, Life Sciences, or related field10+ years of CQV experience in biotech, pharma, or life sciencesStrong understanding of FDA, cGMP, and regulatory requirementsExperience leading CQV for facilities, equipment, utilities, and automation systemsProficiency in project management methodologies (PMP preferred)Excellent communication, problem-solving, and leadership skillsPreferred ExperiencePrior experience with cell & gene therapy, biologics, or vaccine manufacturingHands-on experience with Cleanroom qualification, HVAC, and Water for Injection (WFI) systemsKnowledge of CSV (Computer System Validation) is a plusWhy Join Us?🌍 Work on cutting-edge biotech/pharma projects🚀 Competitive salary + benefits📈 Career growth opportunities in a dynamic, innovative industry

Created: 2025-04-19