CSV Engineer (Pharmaceutical)

TL;DR

CSV Engineer (Pharmaceutical): Responsible for Computer System Validation activities within a pharmaceutical manufacturing environment with an accent on GAMP5, GMP, and regulatory compliance. Focus on developing and executing validation documentation, including Qualification Plans, Test Plans, and RTMs for digital manufacturing systems like MES.

Location: Hybrid (Limerick, Ireland)

Company

hirify.global is a global project management and engineering consultancy specializing in the pharmaceutical and life sciences sectors.

What you will do

• Deliver full CSV lifecycle activities for SynTQ Syncade, including development and execution of test scripts and Requirements Traceability Matrices (RTM).
• Lead validation of MES configurations, master data, audit trails, and electronic signatures in compliance with GMP, GAMP5, and 21 CFR Part 11.
• Coordinate FAT/SAT and system acceptance testing for MES implementations and upgrades, ensuring end-to-end integration with automation systems.
• Develop and maintain Qualification Plans and Validation Test Plans aligned with the overall C&Q strategy.
• Create SDLC documentation, including URS/FRS, Design Specifications, Code Review Documentation, and Validation Summary Reports.
• Collaborate with Automation, IT, Quality, and third-party vendors to ensure data integrity and regulatory compliance.

Requirements

• 5+ years’ experience in Computer System Validation within pharmaceutical or life sciences manufacturing environments.
• Expert knowledge of GAMP5 methodology.
• Proven experience with GMP and Regulatory Compliance.
• Deep understanding of SDLC Documentation and the Validation Lifecycle.
• Experience with FAT/SAT oversight and Requirements Traceability Matrix (RTM) development.
• Strong capabilities in vendor and stakeholder management.