Compliance Engineer, Plant Engineering Compliance

Compliance Engineer, Plant Engineering Compliance page is loaded## Compliance Engineer, Plant Engineering Compliance locations:
Copenhagen, Denmark time type:
Full time posted on:
Posted 2 Days Agojob requisition :
JR102616
** 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.
** At our Copenhagen production site, compliance is critical to keeping manufacturing running safely, efficiently and inspection-ready at all times. Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe.

We are looking for an experienced Compliance Engineer who can independently own and drive Change Control, Deviations and CAPA across clean utilities, calibration, production equipment and maintenance. You will work closely with engineering SMEs, support audits and authority inspections, and actively strengthen the overall quality level within Plant Engineering.
* This position is not intended for early-career profiles. You are expected to step in with confidence and deliver from day one.
*** About the Team
** You will join the Support & Compliance Team within Plant Engineering, part of the wider Engineering organization. The team owns and drives compliance activities for the department, including quality records, procedures, audit coordination and follow-up with QA and external authorities. We work closely with SMEs across utilities, metrology, maintenance and production support.
** About the Role
** Your core responsibility is to ensure that Plant Engineering meets GMP expectations at all times. You will own and drive quality records, support inspections, and continuously improve compliance processes linked to production equipment, clean utilities and facility monitoring systems.

You will act as a key compliance partner for SMEs, guiding them on regulatory requirements and ensuring timely, robust documentation.
** Key Responsibilities
*** Independently handle Deviations, CAPA and Change Control from start to closure
* Drive compliance activities related to clean utilities, HVAC, water systems and production equipment
* Coordinate compliance tasks across departments and with QA
* Prepare and present documentation for audits and authority inspections
* Perform internal investigations, risk assessments and compliance checks
* Maintain and update quality documents and SOPs owned by Plant Engineering
* Support implementation and follow-up of improvement initiatives

This role requires prior GMP experience. There is limited scope for training from scratch
** Your Profile
*** Solid experience working with GxP compliance in the pharmaceutical or biotech industry
* Proven hands-on experience with Deviations, CAPA and Change Control is mandatory
* Experience with utilities, HVAC, water systems or facility equipment is strongly preferred
* Relevant academic background such as Engineering, Pharmacist or similar
* Comfortable working independently in a complex, regulated environment
* Structured, detail-oriented and confident in cross-functional collaboration
* Clear communicator who can challenge constructively and guide SMEs
** Application
* * To apply, please submit your CV. We encourage you to apply, even if you do not meet every requirement. If you need further information about the position, please feel free to contact Katarzyna Holmbjerg, Manager of Plant Engineering Compliance team on   
** Please note that the hiring process for this role will begin in week 1, 2026.
***** 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…