CSV Associate Director (Computer Systems Validation)

Location: Portsmouth, NH, US — onsite

Company

Global life sciences organization developing and manufacturing medicines through connected operations across more than 30 sites worldwide.

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.
• Apply the 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, support audits and regulatory inspections, and develop reusable validation standards and technical guidance.

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, coaching, stakeholder management, and decision-making capabilities.

Nice to have

• Master’s degree or certifications from ISPE/GAMP, Certified Automation Professional, or ASQ.
• Experience with AI or machine learning.

Culture & Benefits

• Agile career environment and dynamic working culture.
• Regional leadership scope across major capital projects.
• Cross-functional exposure to Engineering, CQV, Automation, Digital/IT, Operations, and Quality.
• Career growth opportunities within a global life sciences organization.
• Comprehensive medical, dental, and vision insurance.
• Inclusive and ethical workplace with compensation programs recognizing high performance.