Compliance Engineer

2 weeks ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

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.

The Department and Team
You will be part of the Plant Engineering (PLE) department, responsible for executing technical projects, including facility projects, and overseeing the operation of all utility and facility systems, maintenance, and calibration across our facility. The department currently consists of over 40 employees, including project managers, scientists, engineers, and technicians.

You will report to the Team Leader of the Support & Compliance (S&C) Team in Plant Engineering. The S&C Team handles all quality-related tasks such as deviations, technical system changes, CAPAs, and procedures, as well as our electronic maintenance systems. The team also manages various improvement and system upgrade projects and supports technicians, project managers, and engineers in the department with more complex troubleshooting activities.

The Role
Your responsibilities include cooperating with colleagues within the department and stakeholders from other departments to ensure compliance is maintained at the appropriate level. You will handle quality documents such as deviations, change controls, CAPAs, and procedure updates, working alongside your team members. Familiarizing yourself with the related technical systems is essential to managing your tasks independently. These tasks pertain to components and issues across a range of utility, HVAC, and manufacturing systems.

You will contribute to the continuous improvement of our utilities, facilities, and systems, ensuring that these improvements are implemented within the quality system. In time, you will present documentation during audits and inspections. Your focus will be on both our current and new facilities.

Your Profile

  • Relevant technical background as an engineer or equivalent technical experience in the pharmaceutical or process industry is required.
  • Knowledge of GMP is preferable, along with experience in operations, maintenance, or project participation, and most importantly, a passion for working with quality-related documentation.
  • You are pragmatic and flexible, with a strong focus on achieving goals and a personal drive to complete tasks effectively.
  • You have a structured approach to planning and executing tasks.
  • Good communication skills, including the ability to communicate clearly in both written and spoken English and Danish, are preferred.

Are you up for a challenge?

  • Apply with your CV.
  • If we see a match, you will have a call with one of our recruiters to share more about what you can bring to the team.
  • Are both sides still positive? Then we proceed to the assessment stage to assess key skills required for the job.
  • Applications are screened on an ongoing basis. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation for applying to this position.
  • If you need further information about the position, please feel free to contact Annette Moldestad Knudsen, Team leader of Support and Compliance in Plant Engineering +45 41377967.

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


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