Senior Utility Engineer

AGC Biologics A/S; København; Sur place; DKK 700 000 - 900 000; Plein temps

Résumé du poste

AGC Biologics is expanding its Utility team in Søborg and seeks a Senior Utility Engineer with strong GMP knowledge to own pharma water systems and support 24/7 production.

You will lead troubleshooting, CAPA, and qualifications, collaborating with QA, Maintenance and Project teams to drive improvements while ensuring compliance and patient safety.

Qualifications

• Engineering degree or equivalent technical background with field relevance.
• Strong knowledge of pharmaceutical water systems and GMP/GxP requirements.
• Experience troubleshooting, maintaining and optimizing technical systems.
• Experience with technical documentation, deviations, CAPAs, risk assessments and regulatory inspections.
• Ability to take technical ownership and drive improvements independently.

Responsabilités

• Ensure stable, compliant operation of pharmaceutical water systems.
• Take technical ownership of systems and drive improvements in reliability and performance.
• Maintain technical docs (SOPs, P&IDs, maintenance plans) per GMP.
• Lead troubleshooting, root-cause analysis, risk assessments and CAPA activities.
• Support commissioning, qualification and handover of utility projects to Operations/Maintenance.
• Provide input to CAPEX and OPEX projects.
• Represent Utilities during audits and inspections.

Connaissances

GMP utilities

Pharma water systems

Troubleshooting

Documentation

CAPA

Risk assessments

Formation

Engineering degree

Description du poste

Senior Utility Engineer – Plant Engineering (Søborg)

Keep life-changing therapies moving by keeping our utilities running.

Location: Søborg, Denmark. Please note that AGC Biologics does not offer relocation assistance. Applicants must already reside in Denmark or the Greater Malmö area in Sweden.

AGC Biologics is expanding its Utility team in Søborg and is looking for an experienced Senior Utility Engineer with strong expertise in GMP-regulated pharmaceutical water systems. You will play an important role in ensuring the safe, reliable and compliant operation of utility systems that support our 24/7 research, development and production activities.

About the department

The Utility team is responsible for critical utility systems that support production and laboratory operations at our Søborg site. These include pharmaceutical water systems and other essential utilities. You will work closely with Production, QA, Validation, Maintenance and Project teams in a regulated environment where reliability, compliance and patient safety are key priorities.

The role

As Senior Utility Engineer, you will take technical ownership of GMP-critical water systems across the site. This is a hands‑on, operational role focused on compliance, troubleshooting, risk reduction and continuous improvement. You will work alongside two skilled technicians who carry out scheduled and unscheduled maintenance, while you focus on system performance, technical oversight and long‑term improvements. Your responsibilities will include:

• Ensuring the stable, compliant and efficient operation of pharmaceutical water systems.
• Taking technical ownership of systems and driving improvements to reliability and performance.
• Maintaining technical documentation, including SOPs, P&IDs and maintenance plans, in line with 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 takes place during regular business hours, although occasional evening or weekend work may be required to support our 24/7 production environment. Initially, your primary focus will be pharmaceutical water systems. Over time, your responsibilities may expand to include black and clean utilities, allowing you to contribute more broadly across the Utility team.

Experience and competences

• An engineering degree in mechanical, electrical or chemical engineering, or a similar field, or an equivalent technical background combined with relevant experience.
• Strong knowledge of pharmaceutical water systems and applicable GMP/GxP requirements.
• Experience with troubleshooting, maintenance and optimisation of technical systems.
• Experience with technical documentation, deviations, CAPAs, risk assessments and regulatory inspections.
• The ability to take technical ownership, solve complex problems and drive improvements independently.
• The ability to collaborate effectively with cross-functional teams and communicate technical information clearly.
• Experience with GMP utilities, project handovers, black and clean utilities, regulatory audits and mentoring colleagues is an advantage.

As a person, you are

• You are proactive, independent and comfortable taking ownership of your responsibilities.
• You are structured and solution-oriented, with a strong focus on quality and compliance.
• You communicate clearly, collaborate effectively across teams and enjoy sharing knowledge with colleagues.
• You are comfortable balancing operational priorities with technical documentation and continuous improvement.

AGC offers

At AGC Biologics, you will work with critical utility systems in a dynamic pharmaceutical production environment. You will join a collaborative team where knowledge sharing, ownership and practical problem-solving are valued. The role offers the opportunity to develop your technical expertise and contribute to the reliable operation of systems that support our production activities around the clock.

Who We Are

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Denmark. From our Søborg site, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

AGC Biologics is Your Friendly CDMO Expert – dedicated partners with the expertise and commitment to support our customers and teams. We work with some of the world’s most innovative pharmaceutical companies to develop and manufacture their life‑changing drug products. If you’re motivated by meaningful impact and ready to join our journey, we invite you to explore our current opportunities!