Job details

Documentation Associate

Do you have a flair for compliance and the ability to handle multiple stakeholders? Are you looking for a position where you can take on responsibility? If so, a job at 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 1400 employees working with every aspect of biotech and pharmaceutical production.

About the department

In the department Drug Substance (DS) 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 where you will be part of the DS Documentation team.

About the positions

The DS Manufacturing at FDB in Hillerød is expanding and to support operational readiness, we are seeking a Documentation Associate who will drive the effort of ensuring the creation of new documents or update of current GMP documents to support the expanded production facility.

You will have a vital role in facilitating that relevant information reaches you, to be able to update documentation according to production needs, while simultaneously taking other projects into consideration. The end goal is to deliver a fast, smooth, and “invisible” integration of the expansion into operations from a document perspective.

As Documentation Associate your primary tasks will be:

Creation of new or update of existing operational documents for equipment and instruments in the manufacturing expansion.
On-the-floor activities to receive input and ensure the documentation is ready to use.
Interaction with other major projects on a regular basis and adjustments to any scheduling changes.
Participation in development of schedule for documentation updates and overview of the progress (as documented in our KPIs).
Communication with relevant stakeholders to receive input for the documentation.
Continuous prioritization according to production needs.
The successful candidate will transfer into daily operations or take part in other expansion projects after completion of the current expansion, depending on interest and available opportunities.

Qualifications
You hold a Bachelor or Master’s degree within engineering, science, pharmacy or similar and preferable 2-5 years of experience working with cGMP in the biotech or pharmaceutical industry. At FDB we hire for attitude and expect that you bring your full self to work. We are looking for candidates with drive and a quality mindset, ready to take on responsibilities and develop professionally.
You possess the following attributes:

You are able to navigate on your own, in a team and among many stakeholders.
You are equally motivated by coordinating tasks and working as a SME.
You are very quality-oriented and thorough – being able to take a deep-dive into details.
You have a structured approach to your work and you are accountable for the schedules that you have developed. You can clearly communicate changes and challenges.
You exhibit a “can-do” attitude to meet ambitious deadlines.
You are motivated by challenges and energized by changes – there will be a lot of them.
As you will be part of a small but developing team, you need to be pro-active and self-driven in your approach to work.
You have an informal, humoristic approach to your work and your colleagues.
It is an advantage to possess standard knowledge of biological manufacturing processes as well as basic technical understanding of manufacturing equipment and utilities.
You are fluent in English, both written and verbal.

About FUJIFILM Diosynth Biotechnologies
At FDB 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. If you would like to be part of a rapidly expanding organization with many opportunities, consisting of open, honest, enthusiastic and proud people, then please apply.

Your application
If we have sparked your interest in joining us and your qualification matches our needs, we encourage you to apply for this position by submitting your CV and a motivational letter.

Applications will be reviewed continuously. The first interview is scheduled for week 30, and the second interview will take place after week 33. Applicants should expect delayed response times due to vacations.
For questions please reach out to Documentation Supervisor for Expansion Project, Ida Hemmingsen at +45 41949775.

FUJIFILM Diosynth Biotechnologies is 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.

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.

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CEO of Fujifilm Diosynth Biotechnologies

Lars Petersen

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By Fujifilm Diosynth Biotechnologies

At FUJIFILM Diosynth Biotechnologies our mission is to become the leading and most trusted global CDMO in the industry, and our purpose is to become Partners for Life, Advancing Tomorrow’s Medicine

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FUNDING

Growth

INDUSTRY

Biotech & Pharmaceuticals

TEAM SIZE

1001-5000

LOCATION

Hybrid, based in Research Triangle Park, NC

DATE POSTED