CSV Associate Director, East Coast Lead (Onsite)

Lonza; 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

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.