Senior CSV Engineer: GMP Validation & Compliance Lead

Horizon Controls Group; Tipperary; On-site; EUR 80,000 - 120,000; Full time

Job summary

Horizon Controls Group seeks a Senior CSV Engineer to lead validation for a major pharmaceutical manufacturing and capital project. This role ensures computerised systems meet GMP, GAMP 5, data integrity requirements and 21 CFR Part 11 / EU Annex 11 where applicable.

The ideal candidate has 5–8+ years in CSV within regulated pharma/biotech environments, with strong stakeholder management and cross‑functional collaboration across Engineering, IT, Quality and Operations.

Qualifications

• 5–8+ years in Computer System Validation, preferably pharma/biotech.
• Strong knowledge of GMP/21 CFR Part 11 and EU Annex 11.
• Experience generating and executing CSV lifecycle documentation.

Responsibilities

• Lead and execute CSV activities across manufacturing, labs, automation and IT systems.
• Develop, review and approve validation documents: URS, FDS, IQ/OQ/PQ, traceability matrices, SRs.
• Apply risk-based validation per GAMP 5 and site procedures.
• Ensure systems comply with GMP, data integrity and regulatory requirements.
• Collaborate with Engineering, IT, Quality and Operations throughout the lifecycle.
• Review architecture, configurations, interfaces and data flows from validation perspective.
• Lead/assist validation testing, deviations, CAPAs, and defect management.
• Support commissioning and qualification where systems interface with process equipment.
• Manage validation deliverables from third-party vendors and integrators.
• Support change controls, inspections, audits and continuous improvement of CSV processes.

Skills

CSV validation

GAMP 5

GxP knowledge

Regulatory compliance

Stakeholder management

Education

Degree in Engineering

Degree in Computer Science

Degree in Automation

Tools

Regulatory documentation tools

Job description

Horizon Controls Group seeks a Senior CSV Engineer to lead validation for a major pharmaceutical manufacturing and capital project. This role ensures computerised systems meet GMP, GAMP 5, data integrity requirements and 21 CFR Part 11 / EU Annex 11 where applicable.

The ideal candidate has 5–8+ years in CSV within regulated pharma/biotech environments, with strong stakeholder management and cross‑functional collaboration across Engineering, IT, Quality and Operations.