Senior Utility Engineer: GMP Water Systems Lead

AGC Biologics; København; On-site; DKK 850,000 - 1,050,000; Full time

Job summary

AGC Biologics Søborg site is seeking a Senior Utility Engineer to own GMP-critical water systems and ensure continuous, compliant operation across 24/7 production.

You will lead troubleshooting, CAPA, documentation and cross-functional collaboration, with a focus on reliability, risk assessment and timely handovers of utility projects.

The role requires an engineering degree with strong GMP experience; occasional after-hours work applies, and relocation is not provided.

Qualifications

• Engineering degree in mechanical, electrical or chemical engineering or equivalent.
• Strong knowledge of pharmaceutical water systems and GMP/GxP.
• Experience with troubleshooting, maintenance and optimisation.
• Experience with documentation, deviations, CAPAs and regulatory inspections.
• Ability to own technical issues and drive improvements independently.

Responsibilities

• Ensure the stable, compliant and efficient operation of pharmaceutical water systems.
• Take technical ownership of systems and drive improvements to reliability and performance.
• Maintaining technical documentation, SOPs, P&IDs and maintenance plans per GMP requirements.
• Leading troubleshooting, root cause analysis, risk assessments and CAPA activities.
• Supporting commissioning, qualification and handover of utility projects to Operations and Maintenance.
• Providing technical input to CAPEX and OPEX projects.
• Representing Utilities during audits and inspections.
• Acting as the senior technical contact for water systems and providing guidance to colleagues across the site.
• Most work during regular hours with occasional after-hours support for 24/7 production.

Skills

GMP knowledge

Water systems

Troubleshooting

Technical documentation

CAPA & risk

Audits & inspections

Ownership

Education

Engineering degree

Job description

AGC Biologics Søborg site is seeking a Senior Utility Engineer to own GMP-critical water systems and ensure continuous, compliant operation across 24/7 production.

You will lead troubleshooting, CAPA, documentation and cross-functional collaboration, with a focus on reliability, risk assessment and timely handovers of utility projects.

The role requires an engineering degree with strong GMP experience; occasional after-hours work applies, and relocation is not provided.