CSV Validation Engineer – Automation & GMP

Simotechnology

Dublin

On-site

EUR 70,000 - 110,000

Full time

14 days+

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Job summary

SimoTech is recruiting a CSV Engineer to support validation for a Drug Product Facility project in Co. Dublin. The role requires 6+ years in GMP and validation, with hands-on experience authoring C&Q plans, URS, FAT and IOQ documentation and leading cross-functional teams.

Deep familiarity with 21 CFR Part 11, Eudralex Annex 11, and GAMP 5 is essential. You will ensure compliance and traceability across validation deliverables, maintain SDLC templates, and drive risk assessment and knowledge

Qualifications

Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar.
Minimum 6 years’ experience in GMP and validation disciplines, with strong understanding of pharmaceutical design, build, commissioning, & validation processes.
Knowledge of regulatory compliance such as 21 CFR Part 11, Eudralex Annex 11, and GAMP 5.
Solid technical understanding of computer systems and PLC automation systems, enabling FAT and IOQ protocols to be authored with support from other SMEs.
Experience with MES, PI Data Historian, PCS, Lab systems, QBMS, or inspection line control systems.
Experience with paperless validation systems (Kneat) would be an advantage.
Demonstrate excellent interpersonal and communication skills, with strong attention to detail.

Responsibilities

Authoring and managing the C&Q plan, PCS automation validation plans, URS, FAT, IOQ documentation and summary reports, in collaboration with cross-functional teams.
Monitor FAT and IOQ execution activities, ensuring alignment with test script intent, identifying & resolving protocol issues and executing CSV related tests on lines and equipment.
Ensure all automation deliverables comply with regulations and industry best practice standards.
Maintain consistency and traceability across C&Q plans, automation plans, URS, FAT, SAT, IOQ, RTM and summary reports.
Develop and maintain templates for all SDLC deliverables in compliance with client standards, ensuring consistent implementation of validation strategies.
Conduct system walkdowns and verification of technical documentation and drawings, including P&IDs, as-built drawings, and related engineering documentation, to ensure accuracy and compliance.
Identify risks and recommend improvements to the C&Q and automation qualification strategy, documentation quality, and test execution.
Share key learnings to facilitate effective knowledge transfer for future projects.