Lead CSV Engineer – Life Sciences (GAMP5)

Horizon Controls Group; Tipperary; On-site; EUR 90,000 - 120,000; Full time

Job summary

Horizon Controls Group in Tipperary, Ireland, is seeking a Computer System Validation (CSV) Lead to drive validation for capital projects, ensuring all automated systems are qualified and compliant with GAMP5 and GMP.

You will develop plans, coordinate with IT, Quality, and Engineering, review vendor validation packages, support regulatory inspections, and mentor project teams in SDLC and CSV best practices.

Qualifications

• Bachelor's Degree in CS, engineering, automation, IT, or related discipline.
• Minimum 3 years of CSV experience in Life Sciences or Pharmaceutical manufacturing.
• Expert knowledge of GAMP5 validation methodology.
• Strong SDLC and validation lifecycle understanding.
• Experience producing validation documentation in GMP environments.
• Experience reviewing validation deliverables.
• Experience working with vendors and system integrators on regulated projects.
• Strong stakeholder management and technical writing skills.

Responsibilities

• Serve as CSV SME for capital projects.
• Provide a standardized CSV approach across projects.
• Collaborate with Automation, IT, Quality, Engineering teams.
• Coordinate with vendors and system integrators on validation.
• Develop and maintain Qualification Plans, Validation Plans, and Test Plans.
• Develop, review, and approve SDLC deliverables (RTM, test specs, VSR).
• Ensure CSV deliverables comply with quality procedures and GAMP5.
• Support DDQ teams to meet data integrity and compliance.
• Review vendor validation packages for compliance.
• Provide FAT oversight and validation leveraging assessments.
• Support regulatory inspections and audits as required.

Skills

CSV leadership

Regulatory compliance

SDLC understanding

GAMP5 knowledge

Stakeholder management

Technical writing

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) Lead to drive validation for capital projects, ensuring all automated systems are qualified and compliant with GAMP5 and GMP.

You will develop plans, coordinate with IT, Quality, and Engineering, review vendor validation packages, support regulatory inspections, and mentor project teams in SDLC and CSV best practices.