Senior Validation Engineer - CSV (OT)

and internal quality standards. This role requires a strong understanding of cGMP principles and a proven track record in a pharmaceutical or biotechnology manufacturing environment.

• ◆Responsible for 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.

for validation activities.

• ✓Proven experience with validation of the Process Automation Systems, Distributed Control System (DCS), Manufacturing Control System (MCS), Programmable Logic Controllers (PLC), Building Automation System (BAS) and manufacturing equipment/systems is required.
• ✓Experience with server administration, NetApp storage technologies, and core network infrastructure fundamentals will be a plus.
• ✓Direct validation experience and/or GMP operations experience with increasing levels of responsibility for a wide range of validation projects including validation of large-scale biochemical manufacturing equipment, facilities, utility, automation and computerized systems.
• ✓Strong technical writing, verbal communication, interpersonal and problem-solving skills; ability to work independently and as part of a team, organize and manage individuals as well as lead larger scale projects.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.