Senior CSV Engineer: Digital Manufacturing & GMP

Process Automation – Controls.Instruments.Validations, Inc.; Ireland; Remote; EUR 70,000 - 120,000; Full time

Job summary

PACIV is seeking an experienced CSV Engineer to lead validation efforts for digital manufacturing capital projects in Munster, Ireland. The role focuses on ensuring all automated systems are qualified and validated per GAMP5, SDLC, and regulatory standards.

You will collaborate with Automation, IT, Quality, Engineering, and Digital Manufacturing teams, review vendor documentation, supervise FAT, and deliver CSV plans, RTMs, and validation reports across multinational environments.

Qualifications

• 5+ years of experience in Computer System Validation (CSV) within a pharmaceutical manufacturing environment.
• Expert knowledge of GAMP5 validation methodology.
• Strong understanding of SDLC processes and validation lifecycle requirements.
• Experience developing and executing validation documentation within GMP-regulated environments.
• Demonstrated experience reviewing and approving validation deliverables.
• Experience working with vendors and system integrators on regulated projects.
• Strong stakeholder management, communication and technical writing skills.
• Ability to operate effectively within cross-functional project teams.

Responsibilities

• Serve as CSV SME for digital manufacturing capital projects.
• Provide a standardised CSV approach across projects in alignment with the CSV Lead's strategy.
• Collaborate with Automation, IT, Quality, Engineering and Digital Manufacturing teams.
• Review vendor documentation and validation packages for compliance.
• Develop and maintain Validation Plans, Qualification Plans and Test Plans.
• Ensure CSV deliverables comply with relevant procedures and standards.
• Provide FAT oversight and validation leveraging assessments.
• Support regulatory inspections and audits as required.

Skills

CSV expertise

GAMP5 knowledge

SDLC understanding

Regulatory compliance

Vendor coordination

Education

Engineering or CS degree

Tools

Kneat eVal

Job description

PACIV is seeking an experienced CSV Engineer to lead validation efforts for digital manufacturing capital projects in Munster, Ireland. The role focuses on ensuring all automated systems are qualified and validated per GAMP5, SDLC, and regulatory standards.

You will collaborate with Automation, IT, Quality, Engineering, and Digital Manufacturing teams, review vendor documentation, supervise FAT, and deliver CSV plans, RTMs, and validation reports across multinational environments.