Manufacturing Support Documentation Associate
6 days ago
Manufacturing Support Documentation Associate
Apply locationsHillerod posted on Posted 22 Days Ago job requisition id JR3936
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 consists 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 the impact of events.
About the position
Currently, 1 new position is 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. Perform timely closure of action items to ensure reliable execution of production.
- Continuously 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, preferably 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.
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 they arrive.
For questions or doubts please reach out to Manager in Manufacturing Support Nina Hartling +45 4194 9718.
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 identity or any other protected class.
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