GMP Support Associate

Join Our Team in Hillerod

Would you like to play a vital role in maintaining GMP compliance? And can you drive continuous improvement initiatives to achieve operational excellence?

Then we hope you will join us and embark on a great journey of expanding our Finished Goods Manufacturing (FGM) capabilities and partnering with new and exciting companies!

Your New Role

You will provide daily support to shop floor operations and batch preparation, ensuring compliance with GMP standards and regulatory requirements.

As a Subject Matter Expert (SME), you will represent the organization on projects and investigations, offering valuable insights and guidance to maintain adherence to GMP principles.

Primary responsibilities will include:

• Implementation of Corrective and Preventive Actions (CAPA), driving resolution of non-conformances and promoting a culture of quality and compliance.
• Drive continuous improvement projects aimed at enhancing operational efficiency, reducing waste, and optimizing processes.
• Create and revise GMP documents and ensure compliance across all processes.
• Provide support related to our serialization system.

Your Skills & Talent

• Minimum bachelor's degree in Manufacturing Engineering, Pharmaceutical Sciences, or a related field, providing a solid foundation for understanding GMP principles and practices.
• Excellent communication skills in both English and Danish is required.
• Detail-oriented mindset with a passion for ensuring compliance and upholding the highest standards of quality in all operational activities.
• Flair for understanding new IT systems and data handling.
• Thrive in a work environment of both performing administrative tasks but also being present at shopfloor for e.g. Quality Walks, handling of issues on the production lines and being a constructive contributor in collaborations with different stakeholders.

We hope you are:

A curious team player with a can-do-attitude, a quality mindset and a keen eye for structure thriving in a very dynamic entrepreneurial environment.

Your New Team & Department

The Operations support team consists of 11 highly skilled individuals supporting FGM with a mixture of process, equipment, and GMP knowledge. We are dedicated to supporting each other and collectively owning GMP compliance.

We engage in a wide range of responsibilities and tasks, contributing to a dynamic and challenging work environment. You will work in very close collaboration with the colleagues on the FGM shop floor, but also across the organization – Process Science, Maintenance and Quality among others. We aim to always be curious about the current processes and strive to make an impact on how to work even smarter in the Finished Goods Manufacturing Area.

Our environment is international and informal, emphasizing psychological safety through trust and empowerment, a high pace, and a vital life balance with plenty of fun.

Application

Apply now to be part of our mission to deliver high-quality products to our Partners and Patients worldwide.

Upload your CV and cover letter as soon as possible. We will screen candidates on a continuous basis. For questions, please contact Manager Tinna Buhl phone +45 28101491.

FUJIFILM Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers' product lifecycle, from breakthrough cures to life-saving vaccines.

Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we're enriching communities, protecting the environment, and reimagining healthcare's potential.

Shape the future with us—your drive meets boundless opportunity here https://fujifilmbiotechnologies.fujifilm.com/

FUJIFILM Biotechnologies Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity or any other protected class.