Senior Validation CQV Engineer

Job Title: Senior Validation CQV Engineer Experience: 9+ Years Industry: Pharmaceutical / Biotechnology Position Summary : We are seeking an experienced Senior Validation CQV Engineer with 9+ years of experience in pharmaceutical or biotechnology environments to support a facility expansion and upgrade project in California. The ideal candidate will have extensive expertise in Commissioning, Qualification, and Validation (CQV) of facilities, utilities, and laboratory/manufacturing equipment within a GMP-regulated environment. The candidate will lead validation documentation and execution activities, manage periodic reviews, and ensure systems remain in a validated state of control. Strong knowledge of data integrity principles, Quality Management Systems (QMS), and asset management platforms is essential. Key Responsibilities : Develop, review, and maintain validation documentation, including User Requirements Specifications (URS), Design Specifications, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, and final validation reports. Execute IQ/OQ/PQ activities for facility infrastructure, clean utilities, and QC/manufacturing equipment. Qualify critical pharmaceutical utilities, including HVAC and water systems, along with laboratory and manufacturing instruments such as HPLC systems, bioreactors, and other analytical equipment. Lead periodic reviews of validated systems by evaluating asset management records and QMS documentation, including Change Controls, Deviations, and Corrective and Preventive Actions (CAPA). Assess system performance, compliance history, and overall system health to recommend requalification or continued operation within the validated state. Manage equipment decommissioning, relocation, and requalification activities for existing assets. Ensure validation activities comply with GMP requirements, global data integrity standards, and ALCOA+ principles. Collaborate with Engineering, Quality Engineering (QE), Quality Assurance (QA), and Operations teams to resolve issues and meet project milestones. Maintain accurate, traceable, and audit-ready validation records. Identify compliance gaps and recommend corrective actions to maintain a state of control. Required Qualifications : Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline. 9+ years of validation/CQV experience within the pharmaceutical, biotechnology, or other GMP-regulated industry. Proven experience qualifying pharmaceutical facilities, utilities, and laboratory/manufacturing instrumentation. Hands-on experience with HVAC, pharmaceutical water systems, HPLC, bioreactors, and analytical instruments. Strong understanding of IQ/OQ/PQ protocols, validation documentation, and qualification lifecycle management. In-depth knowledge of data integrity requirements, ALCOA+ principles, and applicable GMP regulations. Experience reviewing and managing QMS records, including Change Controls, Deviations, and CAPA. Familiarity with asset management systems and their use in periodic reviews and equipment lifecycle management. Demonstrated experience with equipment decommissioning, relocation, and requalification. Strong analytical skills to evaluate system performance and compliance data and develop technically sound recommendations. Excellent technical writing, documentation, communication, and cross-functional collaboration skills. Ability to work on-site in California and support project timelines in a fast-paced environment. Preferred Skills : Experience supporting pharmaceutical facility expansions, upgrades, or remediation projects. Knowledge of risk-based qualification and periodic review methodologies. Experience maintaining validated systems in a state of control. Ability to interpret historical validation records, maintenance data, deviations, and change history. Soft Skills : Strong team collaboration and stakeholder management skills. Positive, proactive, and solution-oriented mindset. Ability to coordinate effectively across Engineering, QA, QE, and Operations. Strong attention to detail and commitment to regulatory compliance. Ability to manage competing priorities and deliver quality documentation under tight deadlines. #J-18808-Ljbffr Virtue America