CSV Engineer: GAMP5 Validation Expert for Life Sciences

Horizon Controls Group; Ireland; Remote; EUR 75,000 - 110,000; Full time

Job summary

Horizon Controls Group in Tipperary, Ireland, is seeking a Computer System Validation (CSV) SME to lead validation activities for capital projects. You will ensure all automated systems are qualified and validated in line with GAMP5, SDLC, and GMP standards, working across Automation, IT, Quality, and Engineering teams.

The role emphasizes developing and maintaining CSV documentation, steering RTMs, test scripts, and validation reports, and coordinating with vendors and DDQ teams to ensure data

Qualifications

• Bachelor's degree required in a technical field.
• Minimum 3 years of computer system validation experience in Life Sciences or pharmaceuticals.
• Expert knowledge of GAMP5 validation methodology.
• Strong understanding of SDLC and validation lifecycle in GMP environments.
• Experience reviewing and approving validation deliverables and working with vendors.
• Strong stakeholder management and technical writing skills.

Responsibilities

• Serve as CSV SME for capital projects and provide standardized CSV approach across projects.
• Collaborate with Automation, IT, Quality, Engineering, and system delivery teams.
• Develop and maintain Qualification Plans, Validation Plans, Test Plans, and RTMs.
• Create and review SDLC deliverables and validation documentation (FS/DS/URS/RS).
• Provide FAT oversight, validation assessments, and regulatory-ready documentation.
• Support regulatory inspections, audits, and quality reviews as required.

Skills

CSV SME

GAMP5

SDLC

Regulatory compliance

Stakeholder communication

Education

Bachelor's Degree in Computer Science/Engineering/Automation/IT

Job description

Horizon Controls Group in Tipperary, Ireland, is seeking a Computer System Validation (CSV) SME to lead validation activities for capital projects. You will ensure all automated systems are qualified and validated in line with GAMP5, SDLC, and GMP standards, working across Automation, IT, Quality, and Engineering teams.

The role emphasizes developing and maintaining CSV documentation, steering RTMs, test scripts, and validation reports, and coordinating with vendors and DDQ teams to ensure data