CSV Associate Director, US East Coast - Onsite Leader

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

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.