CSV Engineer

QCS Staffing; Galway; On-site; EUR 60,000 - 80,000; Full time

Job summary

QCS Staffing is seeking a CSV Engineer for a 6-month contract in Galway, joining a global pharmaceutical organisation to support computerised system validation and manufacturing operations.

The role requires leading CSV activities, maintaining validated states, and contributing to QMS records and inspections with strong communication and autonomy in a compliant environment.

Qualifications

• Extensive experience in Computer System Validation within a GxP-regulated environment.
• Strong knowledge of GAMP 5, data integrity principles, Annex 11, and 21 CFR Part 11.
• Proven experience delivering full CSV lifecycle documentation.
• Excellent communication and autonomous work in a compliance-driven setting.

Responsibilities

• Lead CSV activities across GxP systems and prepare validation deliverables.
• Maintain the validated state of computerised systems and perform periodic reviews.
• Manage QMS records including Change Controls, Deviations, Investigations, and CAPAs.
• Support audit readiness and participate in inspections.

Skills

CSV validation

GxP

GAMP 5

Data integrity

QMS

Job description

CSV Engineer - Galway - 6 Month Contract

Are you looking for the opportunity to work alongside a global pharmaceutical organisation in Galway? Our esteemed client is looking for a CSV Engineer to join their team in their existing manufacturing facility in Galway.

CSV Engineer - Galway - 6 Month Contract

Are you looking for the opportunity to work alongside a global pharmaceutical organisation in Galway? Our esteemed client is looking for a CSV Engineer to join their team in their existing manufacturing facility in Galway. The facility is a responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for a CSV Engineer to help maintain manufacturing operations.

What You'll Need

• Lead CSV activities across GxP systems, including preparation and execution of validation deliverables (URS, RA, IQ/OQ/PQ, reports).
• Maintain the validated state of computerised systems and perform periodic reviews to ensure ongoing compliance.
• Manage QMS records including Change Controls, Deviations, Investigations, and CAPAs.
• Support audit readiness by ensuring documentation accuracy and participating in internal/external inspections.

What you'll do

• Extensive experience in Computer System Validation within a GxP-regulated environment.
• Strong knowledge of GAMP 5, data integrity principles, Annex 11, and 21 CFR Part 11.
• Proven experience delivering full CSV lifecycle documentation and managing QMS processes.
• Excellent communication skills and ability to work autonomously in a compliance-driven environment.