Engineer - Manufacturing Equipment Maintenance

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

We are looking for an Engineer for our Manufacturing Equipment Maintenance team. As the engineer in the team you will play a crucial role in improving equipment reliability, our support to our manufacturing lines, and our stakeholder interaction.

We have recently started manufacturing in our new production facility and accordingly we now have two large manufacturing facilities at the site and the team you will be part of is a very important part of achieving successful operation of both facilities.

The department
The Manufacturing Equipment Maintenance team is part of the Plant Engineering area responsible for maintenance and reliable operation of our manufacturing equipment, operation and maintenance of all HVAC and utility systems, and calibration across our current facility. We have today more than 40 employees in the area with technicians, technical engineers, compliance engineers and managers.

The position
You will support reliable performance of the Manufacturing Equipment of our main production areas 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.

The team is currently 8 people (technician, engineers and a manager).

Your main responsibility within your 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).

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.

How to apply
Send your application as soon as possible as we process the applications as we receive them.

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

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
Location: Copenhagen Site