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.