Senior Biopharma C&Q/Shakedown Engineer

Commissioning Agents Inc (CAI)

Limerick

On-site

EUR 90,000 - 120,000

Full time

6 days ago

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Job summary

CAI is seeking a Senior C&Q Engineer to support commissioning activities on a large-scale biopharma project in Limerick. You will lead on-site shakedown, qualification readiness, and coordination with Automation, Utilities, and cross-functional teams.

The role requires 10+ years in CQV/Validation, strong GMP knowledge, and hands-on bioprocess equipment experience with bioreactors, CIP/SIP, and chromatography systems. Travel within Ireland and internationally may be required.

Qualifications

Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline.
10+ years' experience in Commissioning & Qualification / CQV / Validation.
Strong working knowledge of GMP requirements, FDA and EMA regulations.
Strong hands-on upstream and downstream bioprocess knowledge.

Responsibilities

Act as the Commissioning SME for assigned equipment packages from mechanical completion through to handover for qualification.
Lead on-site system setup, shakedown, and performance tuning for stable operation per GEP.
Verify readiness for commissioning with utilities flushed, purged and prepared prior to energisation.
Coordinate with Automation Engineers to support interlock testing and alarms during start-up.
Support deviation resolution and field changes to meet project timelines.