Compliance Engineer, Plant Engineering Compliance

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.

Do you want to play a key role in keeping a GMP production site compliant audit-ready and fully operational

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 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 2500 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.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.