Senior CSV Validation Engineer – Pharma (Onsite)

SimoTech; Leinster; On-site; EUR 90,000 - 110,000; Full time

Job summary

SimoTech is seeking a CSV Engineer to join our biopharmaceutical client project in Co. Dublin. The role is fully onsite and requires a minimum of 6 years’ experience in GMP and validation disciplines, with deep knowledge of regulatory requirements (21 CFR Part 11, Eudralex Annex 11, GAMP 5).

You will author C&Q plans, URS, FAT, IOQ, and related documentation. Candidates should have a strong background in QA/QC interfaces, cross-functional collaboration, and a track record of delivering compliant

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar.
• Minimum 6 years’ experience in GMP and validation disciplines.

Responsibilities

• Authoring and managing C&Q plan, PCS automation validation plans, URS, FAT, IOQ documentation.
• Monitor FAT and IOQ execution activities and ensure alignment with test scripts.

Education

Bachelor’s degree in Engineering, Computer Science, Life Sciences or similar

Tools

Kneat

MES

PI Data Historian

PCS

Lab systems

Job description

SimoTech is seeking a CSV Engineer to join our biopharmaceutical client project in Co. Dublin. The role is fully onsite and requires a minimum of 6 years’ experience in GMP and validation disciplines, with deep knowledge of regulatory requirements (21 CFR Part 11, Eudralex Annex 11, GAMP 5).

You will author C&Q plans, URS, FAT, IOQ, and related documentation. Candidates should have a strong background in QA/QC interfaces, cross-functional collaboration, and a track record of delivering compliant