CSV Engineer: Digital Manufacturing Validation Lead

Process Automation – Controls.Instruments.Validations, Inc.; Munster; On-site; EUR 90,000 - 130,000; Full time

Job summary

PACIV in Munster, Ireland, seeks an experienced Computer System Validation (CSV) Engineer for a site-based role in a multinational life sciences environment. You will lead CSV activities for digital manufacturing capital projects, ensuring systems are validated per GAMP5 and regulatory standards.

Responsibilities include developing plans, reviewing SDLC deliverables, and coordinating with Automation, IT, Quality and Engineering teams. EUA/Irish work eligibility required.

Qualifications

• 5+ years of CSV experience in pharma manufacturing.
• Expert knowledge of GAMP5 validation methodology.
• Strong SDLC processes and validation lifecycle understanding.
• Experience developing and executing validation documentation in GMP environments.
• Experience reviewing validation deliverables with vendors and integrators.
• Excellent stakeholder management and technical writing skills.
• Ability to operate in cross-functional project teams.

Responsibilities

• Act as CSV SME for digital manufacturing capital projects.
• Provide a standardised CSV approach across projects alongside the CSV Lead.
• Collaborate with Automation, IT, Quality, Engineering and Digital Manufacturing teams.
• Review vendor docs and validation packages for compliance.
• Develop Validation Plans, Qualification Plans and Test Plans.
• Ensure CSV deliverables comply with procedures, GAMP5 and regulatory standards.
• Support data integrity and compliance with Digital Data & Quality teams.
• Provide FAT oversight and validation leveraging assessments.
• Assist project teams with CSV guidance, documentation and execution.

Skills

CSV validation

GAMP5

SDLC

GMP

Technical writing

Stakeholder management

Cross-functional teamwork

Vendor management

Education

Engineering/CS degree

Tools

Kneat eVal

Job description

PACIV in Munster, Ireland, seeks an experienced Computer System Validation (CSV) Engineer for a site-based role in a multinational life sciences environment. You will lead CSV activities for digital manufacturing capital projects, ensuring systems are validated per GAMP5 and regulatory standards.

Responsibilities include developing plans, reviewing SDLC deliverables, and coordinating with Automation, IT, Quality and Engineering teams. EUA/Irish work eligibility required.