Senior CSV Engineer - Life Sciences Validation Expert

PACIV; Tipperary; On-site; EUR 70,000 - 110,000; Full time

Job summary

PACIV is seeking an experienced Computer System Validation (CSV) Engineer for a site-based role in Munster, Ireland. The role focuses on providing CSV leadership and support for digital manufacturing capital projects, ensuring systems are implemented, qualified, and validated in line with quality standards and regulatory requirements.

The ideal candidate has 5+ years of CSV experience in a pharmaceutical manufacturing environment, with strong knowledge of GAMP5 and SDLC.

Qualifications

• 5+ years of experience in 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.

Responsibilities

• Serve as CSV SME for digital manufacturing capital projects.
• Provide a standardised CSV approach across projects per validation strategy.
• Collaborate with Automation, IT, Quality, Engineering and Digital Manufacturing teams.
• Review vendor documentation and validation packages for compliance.
• Develop and maintain CSV Plans, Qualification Plans and Test Plans.
• Ensure CSV deliverables comply with quality procedures, GAMP5, SDLC and regulatory standards.
• Partner with Digital Data & Quality to address data integrity and compliance.
• Provide FAT oversight and validation leveraging assessments.
• Support project teams with CSV guidance, document generation and execution activities.
• Participate in project planning and provide input into schedules and trackers.
• Represent CSV in project/IT/quality/stakeholder meetings.

Skills

CSV validation expertise

GAMP5

SDLC

Regulatory compliance

Education

Bachelor's degree in Engineering/CS/Industrial Automation or equivalent

Tools

Kneat eVal

Job description

PACIV is seeking an experienced Computer System Validation (CSV) Engineer for a site-based role in Munster, Ireland. The role focuses on providing CSV leadership and support for digital manufacturing capital projects, ensuring systems are implemented, qualified, and validated in line with quality standards and regulatory requirements.

The ideal candidate has 5+ years of CSV experience in a pharmaceutical manufacturing environment, with strong knowledge of GAMP5 and SDLC.