CSV Associate Director, US East Coast
Lonza
Summary
Join Lonza as the CSV Associate Director, US East Coast, where you will provide strategic, technical, and people leadership for Computerized Systems Validation across a growing portfolio of projects and operations. This highly visible leadership role offers the opportunity to shape validation strategy, drive compliance excellence, and support the delivery of innovative manufacturing capabilities that help improve lives worldwide.
Job description
What you will do
- Lead CSV delivery across the US East Coast capital project portfolio from design through qualification, start-up, handover, and operational readiness.
- Provide technical leadership and governance for computerized systems, automation, and control platforms.
- Ensure consistent application of Lonza's global CSV operating model across projects and system lifecycle activities.
- Lead and develop the regional CSV organization through coaching, resource planning, and performance management.
- Partner with Project Delivery, CQV, Automation, Digital/IT, Operations, Quality, and suppliers to achieve compliant validation outcomes.
- Drive inspection readiness and serve as the accountable CSV subject matter expert during audits and regulatory inspections.
- Develop and implement global standards, reusable validation packages, and technical guidance to improve efficiency and compliance.
What we are looking for
- Bachelor's degree in Computer Science, Engineering, Automation, Information Technology, Life Sciences, or a related discipline.
- Extensive experience in CSV, CQV, Automation, Digital/IT Quality, Engineering, or Project Delivery within regulated GMP environments.
- Strong knowledge of risk-based CSV methodologies and the computerized system validation lifecycle.
- Experience with PLC, DCS, SCADA, MES, laboratory systems, analytical systems, and supporting digital platforms.
- Working knowledge of 21 CFR Part 11, EU GMP Annex 11, data integrity principles, GAMP guidance, and cGMP requirements.
- Demonstrated leadership experience with strong coaching, stakeholder management, and decision-making capabilities.
- Preferred qualifications include a master's degree, ISPE/GAMP, Certified Automation Professional, ASQ certification, and AI or Machine Learning experience.
Requirements
- Bachelor's degree in Computer Science, Engineering, Automation, Information Technology, Life Sciences, or a related discipline.
- Extensive experience in CSV, CQV, Automation, Digital/IT Quality, Engineering, or Project Delivery within regulated GMP environments.
- Strong knowledge of risk-based CSV methodologies and the computerized system validation lifecycle.
- Experience with PLC, DCS, SCADA, MES, laboratory systems, analytical systems, and supporting digital platforms.
- Working knowledge of 21 CFR Part 11, EU GMP Annex 11, data integrity principles, GAMP guidance, and cGMP requirements.
- Demonstrated leadership experience with strong coaching, stakeholder management, and decision-making capabilities.
- Preferred qualifications include a master's degree, ISPE/GAMP, Certified Automation Professional, ASQ certification, and AI or Machine Learning experience.
Benefits
- Medical, Dental & Vision
- Performance-based compensation
- Career growth opportunities
Company overview
Lonza is a pioneering global Contract Development and Manufacturing Organization (CDMO) and a world leader in pharmaceutical manufacturing services. Founded in 1897 in Switzerland, the company has evolved into the first and original CDMO, now operating as one of the largest Western CDMO networks with approximately 19,000 employees across more than 30 sites spanning five continents. Lonza specializes in transforming therapeutic discoveries into life-saving and life-enhancing treatments for patients worldwide. The company's comprehensive services span from early development to drug substance and drug product manufacturing, covering established and emerging technologies including mammalian biologics, small molecules, highly potent APIs, bioconjugates, mRNA, microbial products, and cell and gene therapies. With a focus on cutting-edge science, smart technology, and lean manufacturing, Lonza serves a diverse customer base ranging from emerging biotechs to global pharmaceutical companies, delivering integrated solutions throughout the entire treatment lifecycle.