Upstream Support Specialist

Would you like be responsible for providing technical assistance within process design and process documentation? And do you thrive in conducting risk assessments to ensure relevant risks are identified?

Then we hope you will be our new skilled and dedicated Upstream Support Specialist colleague!

Your New Role
You will be part of the Application Support team and report to the manager for this area.

You will support with problem solving, testing of new development, continues improvement, educate and support new users, and in general be an important player for the digitalized journey we are on.

Furthermore, you will work closely with various business functional teams within upstream issues as needed, while ensuring compliance and consistency of our new build application systems. You will work with the following:

Main Tasks:

• Supporting and approving PRS & URS incl. describing all configurable parameters.
• Run simulations in test harness and review functional design, e.g.: Check match with current MPR and configurability.
• Review Functional Specifications, hereunder review of questions from functional design and ensuring that parameters are correctly described (matching PRS)
• Redline and write SOP/WI.
• Write text instructions for MCF (MES core functions)
• Drive UAT protocols (define test scope incl. DeltaV, Syncade and SAP interfaces, identifying positive and negative scenarios, write test cases) UAT execution, TIR and post-approval.
• Communication, training, and change management.
• Drive implementation, cut over and hypercare activities.

Skills & Knowledge, we hope you possess

• A bachelor’s or master’s degree within Engineering, Pharmacy, Information Technology or similar.
• Minimum of 2 years of experience within Upstream manufacturing processes in the biotechnology or pharmaceutical industry.
• Fluency in English

If you do not meet all the requirements, we encourage you to offer alternative experience that you think would be beneficial in this role.

We hope you are
A proactive, problem-solving team player with a positive can-do attitude. You are a people-person thriving in the interaction with uses at all levels of our organization. We also hope you can envision features and solutions that are not yet fully developed and are motivated by completing complicated challenges in a fast-paced entrepreneur environment.

Your New Team
Our Application Support team consist of 10 other dedicated team members executing our Site strategic project of implementing a Recipe Driven Operation system. This digitalization process will optimize our manufacturing execution processes by replacing manual paper tasks thus enhancing site capabilities.

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 life 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.

Your application:
Has this sparked your interest? Then we urge you to upload your CV and cover letter as soon as possible as we will be interviewing on an ongoing basis. We will take down the advert when the right candidate has been identified.

If you have any questions, please do not hesitate to reach out to Manager Jens Brejl [email protected]

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