Senior Clean Utilities Engineer – GMP Manufacturing SME

Tandem Project Management Ltd.

Waterford

On-site

EUR 120,000 - 150,000

Full time

12 hours ago

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Job summary

Tandem Project Management Ltd. in Waterford seeks a Senior Clean Utilities Engineer to lead GMP utilities including purified water, WFI, clean steam, CIP/SIP and cleanroom HVAC.

The role blends hands-on design and troubleshooting with strategic leadership across projects, compliance, continuous improvement and team development. You will drive URS preparation, technical specs, CAPAs and regulatory readiness, mentor technicians and engineers, and collaborate with Quality, Validation, Production

Qualifications

Bachelor's degree in Mechanical, Chemical or a related engineering discipline.
Advanced GMP/validation certifications would be advantageous.
12 to 15+ years’ experience operating GMP utility systems in high-purity environments.
Senior specialist or SME role with technical leadership experience.
Experience leading utility installations, upgrades and CAPAs.
Experience supporting regulatory inspections as a technical SME.
Knowledge of purified water, WFI, Clean Steam and related processes.
Lean Six Sigma and continuous improvement experience.

Responsibilities

Lead design reviews for PW, WFI, Clean Steam, CIP/SIP and cleanroom HVAC upgrades.
Develop URS and technical specifications for capital projects.
Own root cause investigations, CAPAs and regulatory readiness.
Mentor maintenance technicians and junior engineers; develop training programs.

Job description

Tandem Project Management Ltd. in Waterford seeks a Senior Clean Utilities Engineer to lead GMP utilities including purified water, WFI, clean steam, CIP/SIP and cleanroom HVAC.

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