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Compliance Engineer

2 months ago


København, Denmark AGC Inc 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.

How to Apply (Please note that the recruitment process will start taking place from week 34)

To apply, please submit your CV. We encourage you to apply, even if you don't meet every requirement.

If we see a potential match, one of our recruiters will contact you to discuss your application.

If both sides remain positive after this discussion, we will move forward to the assessment stage to evaluate the key skills required for the job.

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