Manufacturing Support Documentation Associate

Do you have the flair for compliance and can handle many stakeholders? Are you looking for a position where you can take on responsibility? Then a job in FUJIFILM Diosynth Biotechnologies (FDB) might be something for you. We are a worldwide Contract Development and Manufacturing Organization (CDMO) with sites in the US, UK and Denmark. In Hillerød we are currently around 1000 employees working with every aspect of biotech and pharmaceutical production.

About the department
In the department Drug Substance Manufacturing (DSM) Support we are responsible for supporting manufacturing operations with project management and compliance of procedures and documentation. Manufacturing Support consist of approx. 90 employees in 3 teams.

In the DSM Documentation team, we provide procedural support to GMP manufacturing and ensure compliance and document release activities in a timely manner. We create and maintain the document package for Drug Substance Manufacturing (DSM) and perform procedural changes as well as assessing impact of events.

About the positions
Currently 1 new position are open to do the following tasks:

• Create and maintain records and procedures by collecting information from stakeholders to supply manufacturing with compliant documents.
• Start-up events and support investigations by giving input as procedural SME.
• Support the change process by writing SME assessment to ensure procedural alignment. Performs timely closure of action items to ensure reliable execution of production.
• Continuous improve the department processes and support stakeholder improvement projects

Qualifications
We are looking for persons who are responsible, conscientious and ready for professional development. You are able to navigate on your own, in a team and among many stakeholders.

• Educational background is preferably a Bachelor or Master within engineering, science, pharmacy or similar.
• Experience with cGMP and pharmaceutical manufacturing, preferable 2-5 years in the industry.
• Knowledge about Cell Culture and Purification unit operations.
• We are an international company and fluency in English is required.

About FUJIFILM Diosynth Biotechnologies
At FDBD we care about developing our employees! When you start working with us, you are not just starting a new job. It is important that you can work individually as well as in a team and it is important that you take responsibility for your own and your team's continuous development. As employee in DSM Support, you will be thoroughly trained, we will set new realistic goals so that you continue your development and so that we support Fujifilm’s production the best possible way.

Your application
If your qualifications meet our requirements, and we have sparked your interest in joining us, please apply as soon as possible.

We will process the applications as the arrive.

For questions or doubts please reach out to Manager in Manufacturing Support Nina Hartling +45 4194 9718.

About FUJIFILM Diosynth Biotechnologies
We are an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication, and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities, and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team. Learn more at https://fujifilmdiosynth.com/

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) 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 identify or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Location: FDBD Hillerod