Senior Clean Utilities Engineer – GMP Manufacturing Leader

Tandem Project Management Ltd.; Waterford; Hybrid; EUR 110,000 - 150,000; Full time

Job summary

Tandem Project Management Ltd. seeks a Senior Clean Utilities Engineer for a GMP manufacturing site in Waterford, Ireland. You will lead design reviews, troubleshoot PW/WFI/Clean Steam systems and drive compliance across IQ/OQ/PQ, CAPA and validation activities.

This role requires 12–15+ years in pharma utilities, strong leadership, and ability to engage with regulatory bodies such as FDA and HPRA. Travel for conferences and cross-functional collaboration is expected.

Qualifications

• 12–15+ years operating GMP utilities in pharma/biotech or high-purity manufacturing.
• At least 5 years in a senior specialist or SME role with technical leadership.
• Experience leading utility installations, upgrades, and CAPAs.
• Knowledge of PW, WFI generation, Clean Steam, SIP/CIP and cleanroom HVAC.
• Experience supporting regulatory inspections as a technical SME.

Responsibilities

• Lead design reviews for PW, WFI, Clean Steam, CIP/SIP and cleanroom HVAC.
• Develop URS and technical specs for capital projects with proper materials and dead-leg control.
• Act as technical escalation point for utility failures and CAPA investigations.
• Improve maintenance strategies with reliability, energy efficiency and KPIs.
• Prepare for regulatory inspections as SME and support audits.

Skills

Technical leadership

Root cause analysis

HVAC management

Lean Six Sigma

Education

Bachelor's degree in Mechanical/Chemical Engineering

GMP/Validation certifications (advantageous)

Tools

CMMS

IQ/OQ/PQ protocols

PAT technologies

Job description

Tandem Project Management Ltd. seeks a Senior Clean Utilities Engineer for a GMP manufacturing site in Waterford, Ireland. You will lead design reviews, troubleshoot PW/WFI/Clean Steam systems and drive compliance across IQ/OQ/PQ, CAPA and validation activities.

This role requires 12–15+ years in pharma utilities, strong leadership, and ability to engage with regulatory bodies such as FDA and HPRA. Travel for conferences and cross-functional collaboration is expected.