Senior Validation Engineer - CSV (OT)

Lonza - Vacaville, CA

Hiring: Senior Validation Engineer - CSV (OT) Company: Lonza Location: Vacaville, CA Job Posted Time: 2026-09-03 14:48:05 Employment Type: Full-time Target Skills & Keywords : PLC, Risk Management About the job Experience: •5-8 years of experience in validation within the pharmaceutical, biotechnology, or medical device industry. •8 years of experience in validation within the pharmaceutical, biotechnology, or medical device industry. Required Skills: •Lead and oversee oversight and performance of Commissioning and Qualification of computerized equipment, utility systems, facilities, automation control systems, and site computerized systems. •Leverage risk management principles to drive risk-based validation testing and decision-making. •Author, review and approve validation master plans, project plans, validation protocols, validation reports, deviations, and change controls in accordance with Lonza's quality management system. •Develop, execute, and review validation protocols (DQ, IQ, OQ, PQ) for new and modified equipment, processes, and systems. •Peer review/approve validation protocols, and summary reports generated by junior and contract personnel; monitor and track validation schedules and progress, escalating any potential delays or issues to management. •Provide technical leadership by representing Engineering Validation on project teams and coordinate activities of Engineering, MSAT, Manufacturing, Quality, and other Vacaville groups required to manage projects. •Support internal and external audits by providing documentation and technical explanations of validation activities. •Minimum of 5-8 years of experience in validation within the pharmaceutical, biotechnology, or medical device industry. Qualifications: •Medical, dental and vision insurance •Life insurance, as well as short-term and long-term disability insurance Compensation: •$93,000 - $155,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!