Compliance Engineer

Compliance Engineer, Plant Engineering Compliance Team

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.

Would you like to help us secure the quality level of our production plant in Copenhagen where the purpose is to bring hope to life by enabling life-changing therapies for patients around the globe? If you are motivated by driving quality activities and developing the overall quality level, then apply today!

We are seeking an experienced Compliance Engineer to support the areas of clean utilities, calibration, production equipment and maintenance in handling quality records such as Change Control, Deviations and CAPA.

The Compliance team is part of Plant Engineering, which falls under the broader Engineering division. Plant Engineering is responsible for manufacturing maintenance of production assets, metrology, utility operations, and asset management. With a strong service mindset, Plant Engineering delivers reliable and professional support across the entire Copenhagen site.

The purpose of the Support & Compliance Team is to provide compliance support and drive Deviation, Change Control and CAPA records, and maintain procedures owned by the department. Moreover, the team ensures coordination and follow-up on external audits and authority inspections.

About the role

Your capabilities within quality compliance, coordination and overview are key for the department's ability to pass inspections from customers & authorities. You will contribute to continuous improvement of our quality processes connected to production equipment, clean utilities and facility monitoring systems and oversee Plant Engineering's part of the overall quality system.

You will participate in presentation of documentation at audits and inspections and guide the SMEs on regulatory compliance.

Primary responsibilities will include:

• Coordinating tasks related to compliance across departments.
• Assisting in the implementation and monitoring of compliance controls, compliance procedures, and operational processes.
• Conduct internal investigations on compliance issues and identify vulnerable areas and risks.
• Implementation and follow-up on improvement projects in close collaboration with other stakeholders and QA.
• Compliance check and verification of processes and procedures.
• Handling of quality records such as Change Control (CC), Deviations (DEV), Corrective and Preventive Actions (CAPA), and maintenance of quality documents and SOPs.

Your profile

Relevant academic background e.g., Engineering degree, Pharmacist or equivalent. It is expected that you have solid experience working with GxP compliance from the pharmaceutical industry. You adapt quickly to new situations in a changing environment, and you are leading the way when sharing knowledge and learnings with your colleagues. You have a structured approach to planning and execution of your tasks. You are a strong communicator and find it natural to establish relationships across the organization.

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 by mail: kholmbjerg@agcbio.com. If we see a potential match, one of our recruiters will contact you to discuss your application.

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. 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.