Senior Clean Utilities Engineer - GMP Pharma SME

Careerwise Recruitment; Waterford; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Careerwise Recruitment is recruiting a Utility Engineer for a leading pharma site in Waterford on a 23-month contract. The Senior SME will own GMP critical utility systems including Purified Water, Water for Injection, Clean Steam, CIP/SIP and cleanroom HVAC, with 75% hands-on execution and 25% strategic leadership.

The role requires 8–10+ years in GMP utilities, a Bachelor’s degree in Engineering, and experience leading audits, qualification protocols, and vendor management.

Qualifikationen

• Bachelor’s degree in Mechanical, Chemical, or related engineering.
• 8–10+ years in GMP critical utility systems in pharma or high-purity manufacturing.
• 5+ years in a Senior SME role with audits, qualification protocols, and change control.

Aufgaben

• Oversee design integrity and troubleshoot PW, WFI, CS, CIP/SIP systems, and cleanroom HVAC.
• Lead technical design reviews and author URS documents; manage vendors/OEMs for capital projects.
• Act as primary SME during regulatory inspections (FDA, HPRA) and ensure compliance with Pharmacopeial, ISPE, and ASTM standards.
• Drive CAPAs, Lean/Six Sigma initiatives, and pilot digital technologies (PAT, IoT, predictive maintenance).
• Coach and upskill technical teams and represent the site in global networks (ISPE, ASHRAE).

Kenntnisse

GMP utilities

IQ/OQ/PQ

Root cause analysis

Change control

CMMS

Audits

Lean Six Sigma

PAT

IoT

Mentor teams

Vendor management

Ausbildung

Bachelor's degree in Engineering

Jobbeschreibung

Careerwise Recruitment is recruiting a Utility Engineer for a leading pharma site in Waterford on a 23-month contract. The Senior SME will own GMP critical utility systems including Purified Water, Water for Injection, Clean Steam, CIP/SIP and cleanroom HVAC, with 75% hands-on execution and 25% strategic leadership.

The role requires 8–10+ years in GMP utilities, a Bachelor’s degree in Engineering, and experience leading audits, qualification protocols, and vendor management.