CSV Associate Director, US East Coast Leader

Lonza Group Ltd.; Portsmouth (NH); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Agile career culture

Career growth opportunities

Global life sciences employer

Job summary

Lonza Group Ltd. is seeking a CSV Associate Director for the US East Coast, based in Portsmouth, NH, onsite. Lead validation strategy, governance, and the regional CSV organization across major capital projects to deliver compliant, efficient validation outcomes.

T whole governance and cross-functional collaboration with Engineering, CQV, Automation, Digital/IT, Operations, and Quality will be essential to success. Global standards and inspection readiness are key responsibilities.

Qualifications

• 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.

Responsibilities

• 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.

Skills

CSV

CQV

Automation

Digital/IT Quality

Engineering

Project Delivery

GMP compliance

PLC

DCS

SCADA

MES

Laboratory systems

Analytical systems

Digital platforms

Education

Bachelor's degree in Computer Science, Engineering, Automation, Information Technology, Life Sciences, or related discipline

Master's degree (preferred)

Tools

ISPE/GAMP

Certified Automation Professional

ASQ certification

Job description

Lonza Group Ltd. is seeking a CSV Associate Director for the US East Coast, based in Portsmouth, NH, onsite. Lead validation strategy, governance, and the regional CSV organization across major capital projects to deliver compliant, efficient validation outcomes.

T whole governance and cross-functional collaboration with Engineering, CQV, Automation, Digital/IT, Operations, and Quality will be essential to success. Global standards and inspection readiness are key responsibilities.