Process supporter for Wash, Autoclave & Support, Drug Product Manufacturing

Does introducing new products into a brand-new facility sound exiting to you? And do you have experience from Drug product manufacturing or aseptic manufacturing?

Then come and join us and be a vital part of advancing tomorrow’s medicine in our new innovative Drug Product facility!

Your New Role
You will become part of an enthusiastic, and dedicated, team responsible for Wash, autoclave and support of our drug product. Together, with your team, you will be responsible for implementation of operational processes and procedures within the wash and autoclave area for DP, while also supporting the more overall processes of batch record handling, electronic logbooks and other systems.

During the next year we will support the initial Aseptic Process Simulation (APS) and take part of introducing of our first products into manufacturing. You will work in close cooperation with our many stakeholders to assure that we get all documentation ready for PPQ and subsequent manufacturing.

Subsequently the team will support the daily operations in the wash and autoclave area and take part of Technology Transfer activities related to introduction of new products from our partners.

Primary tasks will be:

• Prepare/Update operational documents (SOP’s and WI’s).
• Support creation of electronical Master Batch Records (PAS-X and Tulip).
• Participate and support activities related to initial and ongoing Aseptic Process Simulation (APS).
• Participate in Tech transfer activities and implementation of new programs for our area.
• Participate and contribute to Risk assessments related to ongoing manufacturing and new products.
• Fist line supporting role for DP operation including Training of colleges.
• Support handling of events and deviations
• Drive or support changes for our area.
• Continues Improvements on e.g. flows of personnel, materials and equipment, Change Controls and document updates.
• Identification and implementation of corrective and preventive actions (CAPA’s) to prevent re-occurrence and improve compliance.

Your Talent & experience:

• You have a bachelor’s or master’s degree within Pharmaceutical Sciences, Process Engineering, or similar degree.
• Preferably, you have a minimum of 1-2 years of experience within aseptic manufacturing in the Pharmaceutical/Biotech industry. We can adjust the position according to your experience.
• You can work independently on compliance related tasks, events, and optimization projects.
• You can manage multiple stakeholders and is motivated by the interface between QA, MSAT and Manufacturing.
• You understand regulatory requirements and can execute within their framework.
• You have a high level of technical writing skills and excellent communication skills in English and Danish (spoken and written).

We hope you are:
Curious of nature, meet and greet people with a smile and you seek solutions when faced with a challenge or problem. You work with humility and respect for the people around you. You are flexible and able to prioritize tasks to meet defined timelines. You work structured with a quality mind set and enjoy cooperating as well as working independently.

Your New Team & Department
The Drug Product Manufacturing department will consist of approx. 60 dedicated and enthusiastic employees when the first filling suite is ready for production. DPM currently contains five teams covering Wash & Autoclave, Filling, Program support, Continuous improvement, Formulation and Inspection.

We keep a high pace and focus on a vital work life balance while having fun. We believe in bringing different experiences and educational backgrounds into play and the common denominator of the department is acknowledgement and development of each employee.

We put a strong emphasis on psychological safety, trust and empowerment within our teams and hope that this is something that speaks to you as well.

Application
Has this sparked your interest? Then we urge you to send an updated CV and cover letter as soon as possible. We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.

If you have any questions, please do not hesitate to reach out to Hiring Manager Christer Flade 45 23369297

FUJIFILM Diosynth 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://fujifilmdiosynth.com/

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