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Engineer - Manufacturing Equipment Maintenance

Employer: AGC Biologics
Location: Copenhagen

We are looking for a Manager for our Manufacturing Equipment Maintenance team. We will during 2023 have two manufacturing facilities to operate when our new EUR 160 million Mammalian Manufacturing Facility is getting into operation – and you will play an important role.

The position
You will ensure reliable performance of the Manufacturing Equipment on one of our main production areas – your focus area - via proactive maintenance including life cycle management based on maintenance & repair history for the equipment, input from the manufacturing users and input from the equipment vendors/service partners. Due to our growth we have decided to modify our set-up to include a dedicated team with this focus.

The team is during the coming year expected to grow to 8-10 people (technician, engineers and a manager).

Your main responsibility within your focus area covers:

  • Ensure compliance and audit readiness of the maintenance activities for manufacturing equipment
  • Keep maintenance plan and procedures for current manufacturing equipment up to date
  • You work side by side with the maintenance technicians in coordination of maintenance activities is carried out timely with internal and external stakeholders
  • You work closely together with the maintenance technicians to ensure that maintenance of manufacturing equipment is carried out and documented as required
  • Ensure maintenance plan is in place when on-boarding of new manufacturing equipment
  • Ensure services agreements are in place and maintain spare part list for manufacturing equipment
  • General maintenance life cycle management for manufacturing equipment including continuous improvement of manufacturing equipment maintenance programs
  • Fast follow-up on break down situations
  • Provide document investigation for manufacturing equipment in case of break down
  • Contribute to quality documentation as required (changes, CAPA, deviations).

You will act as a partner towards our production areas to ensure that we have a common understanding of the technical activities that impact the manufacturing equipment.

A significant part of our maintenance and repair activities are done by external companies meaning that you will also will be involved in this external interface.

You work closely with stakeholders in the manufacturing organization.

Your profile
  • Relevant engineering degree or similar technical background from the pharmaceutical or biotechnology industry with GMP experience.
  • Prior experience from maintenance of production systems and/or utility systems including changes to such systems is preferred. However we will also welcome newly graduated engineers. Dependent of the profile we will adjust the tasks within the responsibility area.
  • Knowledge about automation and control systems.
  • Good at planning, coordination and execution of activities.
  • You have good cooperation skills and can take decisions.
  • You work systematically and are at the same time and capable of handling a dynamic environment without losing overview.
  • Good communication skills – including the ability to communicate clearly and professionally in written and spoken English and Danish is preferred.

If you need further information
about the position, please feel free to contact Jesper Sandholm Hansen, Sr. Director Engineering Operations + 45 25578027.

The department
The Manufacturing Equipment Maintenance team is part of the Engineering and Operations Support (EOS) department responsible for execution of technical projects including facility projects, facility management as well as operation of all utility, maintenance and calibration across our current facility. The department consist today of around 45 employees with project managers, engineers, compliance specialist and technicians.
Degrees of interest: Engineering degree or similar technical background from the Pharmaceutical/Biotechnology industry