Clean Utilities Technican

Our client who is a leading pharmaceutical company has a requirement for a Utility Technician based in Waterford. This is a 23-month contract position.  This role oversees regulatory compliance, quality oversight, data integrity, and engineering performance for critical clean utilities systems—including Water for Injection (WFI), Purified Water, Clean Steam, HVAC, and Compressed Air. This would be a 2-cycle shift.

The ROLE

• Ensure clean utilities adhere to cGMP, EU GMP Annex 1, FDA guidelines, and pharmacopeial standards (USP, EP, JP).
• Oversee system qualification, validation, and requalification cycles (IQ/OQ/PQ).
• Coordinate audit/inspection readiness and manage regulatory responses.
• Monitor critical quality attributes (CQAs/CPPs), microbiological/chemical testing, and out-of-specification (OOS/OOT) trends.
• Manage QMS tasks including deviations, CAPA, change controls, and Quality Risk Management (ICH Q9).
• Drive root-cause investigations (5-Why, Fishbone, FMEA) for failures to minimize process deviations and discards.
• Conduct periodic quality reviews, system risk assessments, and vendor oversight.
• Serve as the ALCOA+ Champion across paper records and automated systems (SCADA, Historians, LIMS, MES).
• Enforce compliance with 21 CFR Part 11 and EU Annex 11.
• Manage system security, user access controls, audit trail reviews, and backup strategies to prevent unauthorized data changes.
• Approve engineering modifications, calibrations, and equipment upgrades

REQUIREMENTS

• Qualification in Engineering (Chemical, Mechanical) or Science (Chemistry, Microbiology, Pharma Sciences).
• 3- 5 years in pharmaceutical manufacturing with direct clean utilities exposure.
• 3+ years in a GMP quality, engineering, or compliance role.
• Hands-on experience with qualification, validation, and compliance monitoring for utility systems.

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical                            rofessionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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