Cleaning Validation Specialist

We are looking for a Cleaning Validation Specialist to join our talented and highly experienced Validation Team. So, are you a team-player and used to working in an international environment? Would you like to design and implement our new cleaning validation strategies and play a vital role in ensuring our patient’s safety never gets compromised? Then we are looking for you.

Your role

You will be maintaining qualified cleaning processes and procedures, optimize our cleaning philosophy to support the ongoing production and cleaning validation for new systems delivered as part of our production capacity expansion. This will include optimization of cleaning validation requirements during change-over between production campaigns and the application of risk based approaches to support streamlined cleaning validation.

Main responsibilities

The successful candidate will

Qualifications

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 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, chamber validation, 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. Validation is part of the global organization there has responsibility for aligning between the sites.

Application

Has this caught your attention then we urge you to upload your English CV and cover letter as soon as possible, as we screen and interview candidates on an ongoing basis.

If you have any questions, please do not hesitate to contact Hanne Toft, Sr. Manager Validation at +45 23712992.

FUJIILM 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.

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.