Clean Utilities Technican

Careerwise Recruitment; Waterford; On-site; EUR 60,000 - 80,000; Full time

Job summary

Careerwise Recruitment is seeking a Utility Technician for a leading pharmaceutical client based in Waterford, Ireland. This 23-month contract role focuses on compliance, quality oversight, data integrity, and engineering performance for critical clean utilities systems including WFI, Purified Water, Clean Steam, HVAC, and Compressed Air.

You will operate in a regulated environment ensuring adherence to cGMP, EU GMP Annex 1, FDA guidelines, and pharmacopeial standards.

Qualifications

• 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.

Responsibilities

• 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 CQAs/CPPs, microbiological/chemical testing, and 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.

Skills

Regulatory compliance

Quality oversight

Data integrity

GMP experience

Audits & inspections

QMS & CAPA

Root-cause analysis

ALCOA+ governance

21 CFR Part 11 / EU Annex 11

Education

Engineering (Chemical, Mechanical) or Science (Chemistry, Microbiology, Pharma Sciences)

Tools

SCADA

Historians

LIMS

MES

Job description

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.