Drug Product Automation Engineer

Would you like to contribute to timely and vital Drug Product delivery for the Formulation, Fill/Finish and Visual Inspection Processes? And do you thrive working in cooperation with scientists / SMEs?

Then we hope you are our new proactive and skilled colleague to join our Manufacturing Sciences and Technology Drug Product (MSAT DP) team!

Your New Role
You will be taking up the role of Automation Engineer / SME for our Drug Product Manufacturing (DPM) Technologies. The scope is responsibility for the management of the IT/ Automation systems for Washer, Autoclave, Formulation, PUPSIT, Fill/Finish, Sterility Test Isolator and Visual Inspection including dedicated Scada and engineering stations for the listed equipment.

You will work with the relevant process and technology specialists to ensure robust systems management including the planned maintenance tasks.

You will also be working with our US site based in Holly Springs North Carolina. The US site will come online in 2026. The technologies are similar across sites and the intent is to maintain a high degree of alignment and harmonization and best practices sharing between the sites.

Main Tasks.

• User Administration
• Performance Monitoring Management
• Data Security management
• System admin SOP Updates and ensuring the system admin Standard Operating Procedures (SOPs) are followed
• Change Management (change and configuration management)
• Deviation management/CAPA
• Patch Management
• Periodic Review to ensure the compliance stage of the systems
• Disaster recovery/Backup management
• Data Integrity (Maintaining the IT Risk Assessments)
• Vendor SLA’s

Skills & Knowledge, we hope you possess:

• Relevant Experience from the pharmaceutical industry working in a GMP environment, incl. experience with pharmaceutical manufacturing equipment.
• We welcome applications also from recently graduated that bring a curiosity and mindset of developing within and mastering complex processes and technologies and who has been working in Automation / IT.
• Interest and bandwidth for continually learning about new technologies, processes, and products.
• Strong communication skills in English (spoken and written).
• Profound analytic skill
• Self-drive, proactivity and experience with managing complex assignments.

Your New Team & Department
MSAT DP contains the drug product process and technology scientists/specialist as well as the tech transfer leads, the CQV specialists and the DP development Lab analysts. We are growing from currently around 15 colleagues as we get closer to clinical and commercial drug product manufacturing operations starting early 2025.

We are team players, entrepreneurs, and people who both like details and taking greater responsibility beyond our scope of work.

The work environment is international and informal. We keep a high pace and focus on a vital work balance while having fun. We put a strong emphasis on psychological safety through 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 please upload your CV and cover letter as soon as possible as we will screen candidates on a continuous basis and call in for interviews. Please do not hesitate to reach out to Director Henrik Hermann +45 25 66 30 55 for further details.

The Company
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.

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, colour, 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