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

Lonza Group; Portsmouth (NH); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Agile culture

Regional CSV leadership

Cross-functional exposure

Global company

Medical insurance

Job summary

Lonza is seeking a CSV Associate Director to lead validation across the US East Coast from design through qualification and start-up. This onsite role in Portsmouth, NH stresses governance of computerized systems, automation platforms, and lifecycle activities with cross-functional engagement.

You will role-model leadership, coach the regional CSV team, and partner with Engineering, CQV, Digital/IT, Operations, and Quality to ensure compliant outcomes and readiness for inspections.

Qualifications

• Bachelor's degree in Computer Science, Engineering, Automation, Information Technology, Life Sciences, or 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 validation lifecycle.

Responsibilities

• Lead CSV delivery across the US East Coast capital project portfolio from design through qualification, start-up, 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 lifecycle activities.
• Lead and develop the regional CSV organization through coaching, resource planning, and performance management.
• Partner with cross-functional teams to achieve compliant validation outcomes.
• Drive inspection readiness and serve as the accountable CSV SME during audits/regulatory inspections.
• Develop and implement global standards and reusable validation packages.

Skills

CSV

CQV

Automation

Digital IT

Engineering

Leadership

Decision making

Education

Bachelor's degree in a relevant field

Master's degree (preferred)

Tools

PLC

DCS

SCADA

MES

Laboratory systems

Analytical systems

Digital platforms

Job description

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

United States, Portsmouth (New Hampshire)

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.

Reference: R79561

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.