Senior GMP Clean Utilities Engineer

Tandem Project Management Ltd.; Waterford; Vor Ort; EUR 95.000 - 130.000; Vollzeit

Zusammenfassung

Tandem Project Management Ltd. in Waterford is currently seeking a Senior Clean Utilities Engineer for GMP manufacturing utilities, including PW, WFI, Clean Steam, CIP/SIP and cleanroom HVAC.

You will lead design reviews, develop URS and technical specifications for capital projects, and act as a technical escalation point for complex issues. You will drive regulatory readiness across QA, Validation and EHS, mentor technicians and engineers, and push reliability and energy-efficiency

Qualifikationen

• Degree in engineering; GMP knowledge beneficial.
• Experience with GMP utilities and regulatory readiness.
• Leadership experience in cross-functional teams.

Aufgaben

• Lead technical design reviews for PW, WFI, Clean Steam, CIP/SIP and cleanroom HVAC systems.
• Develop URS and technical specifications for capital projects.
• Act as the technical escalation point for complex utility failures and CAPAs.
• Use trend and failure mode analysis to resolve issues and prevent recurrence.
• Act as SME during regulatory inspections and audits.
• Ensure compliance with pharmacopeial water/steam quality and qualification activities.
• Lead reliability and energy efficiency improvements using Lean/Six Sigma.
• Coach maintenance technicians and junior engineers; support succession planning.

Kenntnisse

Lean Six Sigma

HVAC management

CAPA

Root cause analysis

Regulatory inspections

CMMS

Technical leadership

Cross-functional collaboration

Ausbildung

Bachelor's degree in Mechanical, Chemical or related engineering

Advanced GMP/validation certifications advantageous

Tools

CMMS

Jobbeschreibung

Tandem Project Management Ltd. in Waterford is currently seeking a Senior Clean Utilities Engineer for GMP manufacturing utilities, including PW, WFI, Clean Steam, CIP/SIP and cleanroom HVAC.

You will lead design reviews, develop URS and technical specifications for capital projects, and act as a technical escalation point for complex issues. You will drive regulatory readiness across QA, Validation and EHS, mentor technicians and engineers, and push reliability and energy-efficiency