Role overview
We’re supporting a GMP-regulated manufacturing project in Ireland and are looking to engage an experienced CSV Engineer to support validation and field execution activities across automated and process-related systems.
This role is suited to engineers who are comfortable operating across both documentation and hands‑on field execution, supporting commissioning, qualification and validation activities within a live project environment.
You’ll work closely with engineering, automation, QA and vendor teams to support Computer System Validation (CSV) activities from system assessment through to execution and handover.
The role requires a strong understanding of regulated validation environments, combined with the ability to support activities directly in the field.
Key responsibilities
Support Computer System Validation (CSV) activities within a GMP-regulated environment
Generate and execute:
URS
DQ
RTM
IOQ protocols and reports
Support commissioning and field execution activities from energisation through to handover
Perform P&ID walkdowns alongside engineering and construction teams
Support troubleshooting and deviation resolution during field execution
Review vendor FAT / SAT documentation and support SAT activities
Support systems interfacing with PCS / automation platforms
Work closely with QA, engineering, automation and vendor teams
Ensure compliance with:
GMP regulations
GAMP5
21 CFR Part 11
EU Annex 11
Data Integrity requirements
Strong experience within Computer System Validation (CSV) in GMP environments
Experience working with Siemens-based systems / platforms
Hands‑on experience supporting field execution and commissioning activities
Experience generating and executing validation documentation (URS, DQ, RTM, IOQ etc.)
Strong troubleshooting capability within live project environments
Understanding of GMP, GAMP5 and Data Integrity principles
Experience within pharmaceutical or biotech manufacturing environments
Ireland-based role
Contract position with long‑term potential
Site-based project environment
Suitable for engineers with a balance of technical documentation and field execution experience
If you’re a CSV Engineer with experience supporting GMP-regulated projects and are open to an Ireland-based contract role, I’d be keen to have a conversation.
Apply directly or message me for more details.
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