Clean-in-place Expert for Validation

Do you want to join an advanced biotech company that develops and manufactures some of the leading biological products on the market today and for the future? Then join FUJIFILM Diosynth Biotechnologies (FDB), a biotech company that aspires to be the leading CDMO within our areas of expertise.

Do you want to have a vital role ensuring patients’ safety never gets compromised, by ensuring qualified cleaning processes and procedures. Then maybe you are the new CIP (Clean-in-place) SME (Subject Matter Expert) that we are looking for to join our Hillerød Validation team.

Your role
As CIP SME, you will have responsibility for our new CIP skids in the expansion project. You will represent validation in the green field expansion project for the first 2 years. You will help with family approach for the CIP skids, strategy for OQ and PQ testing, updating the cleaning procedures, as well as helping with cleaning validation for new systems delivered as part of our production capacity expansion. This will also include optimization of CIP procedures and the application of risk based approaches to support streamlined cleaning validation.

Main responsibilities

• Act as the go to person for complex CIP challenges locally at FDBD Hillerød and globally in cooperation with local SME’s at sister sites within the wider organization
• Optimize the CIP procedures, including the application of family approach for cleaning.
• Act as Validation Department SME for review and approval of CIP OQ testing, clean hold and soil hold
• Support the expansion project and secure alignment between the project and the site CIP setup.
• Responsible for implementation of the new CIP skids in our procedures.
• Participate in sustainability projects to reduce the amount of water used by optimizing the CIP processes.

The successful candidate will

• Extensive experience in working with CIP, preferably with a background in biologics drug substance manufacturing.
• Have up to date knowledge of regulatory requirements and current industry trends in the area
• Have a good general understanding of biological drug substance manufacturing, preferably from multi- product production and multi-line facilities.
• Experience with working as part of a green field project.
• Have excellent communication/ presentations skills and be able to articulate complex information to management and support functions (QA, Engineering, Automation and other.)
• Be a team player who works well with colleagues and cross-functional teams.

You hold a bachelor’s or higher degree in a relevant discipline and have at least 7-8 years of relevant industry experience from biological drug substance manufacturing and at least 3 years of experience in CIP. You are self-starting and have a flexible, dynamic approach to work. You bring a friendly, can-do demeanor, professionalism, and a good sense of humor.

About the area
Process Technology is a group of +100 employees that includes 5 departments: Automation, Process Engineering, Validation, Engineering Science and CAD services. We provide support to site-wide projects by offering our expertise as Automation, Process and Validation Engineers and we maintain overall responsibility for ensuring smooth daily operation including engineering technical leadership, and engineering technical support for all cell culture, purification, and pharmaceutical processing equipment.

About the team
The Validation department is part of a Global organization. The Validation department is responsible for maintaining the validated state of equipment within the large-scale manufacturing drug substance facility. This includes qualification of new equipment, cleaning validation, ownership of cleaning validation and equipment qualification strategy, participation in projects/changes and technology transfers for new products. The department supports the existing production facility but is also a huge part of the large expansion projects.

Your application
For more information about the open position, please contact Martin Therkelsen, Manager Validation at +45 2566 3099. Please upload your CV and cover letter in English as soon as possible as we screen candidates on a continuous basis. The Job Ad will be removed when the right candidate has been identified.

Working at FUJIFILM Diosynth Biotechnologies
We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.

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.

Location: FDBD Hillerod