Computer System Validation (CSV) Associate Director, US East Coast

Lonza Inc.; Portsmouth (VA); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Career growth opportunities

Inclusive workplace

Job summary

Lonza Inc. is seeking an experienced CSV Associate Director for the US East Coast, based onsite in Portsmouth, NH. You will provide strategic and technical leadership for Computerized Systems Validation across a growing project portfolio, shaping validation strategy and ensuring compliance.

You will drive regional CSV delivery, develop the local CSV team, and partner with Engineering, CQV, Automation, Digital/IT, Operations, and Quality to achieve compliant outcomes.

Qualifications

• Experience in CSV within regulated GMP environments.
• Strong knowledge of 21 CFR Part 11, EU GMP Annex 11, data integrity, and GAMP guidance.
• Leadership experience with coaching, stakeholder management, and decision-making capabilities.

Responsibilities

• Lead CSV delivery across US East Coast capital project portfolio from design through qualification and start-up.
• Provide technical leadership for computerized systems, automation, and control platforms.
• Ensure application of Lonza's CSV operating model across projects.
• Develop and lead regional CSV organization through coaching and performance management.
• Collaborate with Project Delivery, CQV, Automation, Digital/IT, Operations, Quality, and suppliers.
• Drive inspection readiness and serve as the CSV SME during audits and regulatory inspections.
• Develop global standards, reusable validation packages, and technical guidance.

Skills

Leadership

CSV expertise

Risk-based validation

Stakeholder management

Coaching & development

Strategic leadership

Education

Bachelor's degree (CS/Engineering/Automation/Life Sciences)

Master's degree preferred

Tools

PLC

DCS

SCADA

MES

Lab systems

Job description

Computer Systems Validation (CSV) Associate Director, US East Coast

Location: Portsmouth, NH, Onsite

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.

What you will get

• An agile career and dynamic working culture.
• The opportunity to lead regional CSV strategy and execution across major capital projects.
• Exposure to cross-functional leadership teams spanning Engineering, CQV, Automation, Digital/IT, Operations, and Quality.
• Career growth opportunities within a global life sciences organization.
• Compensation programs that recognize high performance.
• Comprehensive medical, dental, and vision insurance.
• An inclusive and ethical workplace that values diverse perspectives.

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.

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.