Validation Engineer

Are you looking for new and exciting challenges in validation?

Fujifilm Diosynth Biotechnologies (FDB) in Hillerød is expanding, and to ensure support to the continuous growing number of equipment and systems, we are looking for a Validation Engineer, sharing our passion, drive, and energy – to join our team.

We are looking for Validation Engineers who will complement the team’s current skills and with experience in one or more of the below listed areas:

• Qualification of process equipment in Cell Culture or Purification (Up-/Down-stream)
• Qualification of Cleaning in place (CIP) or steaming in place (SIP)
• Cleaning validation

In the first half year, you are expected to support the Performance Qualification for our expansion project. After that you will move on to the Validation department and join the Validation team for Up- or Down-stream. Responsible for Validation of equipment changes and Cleaning Validation in relation to Tech Transfer of new products.

About the department and 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, participation in projects/changes and Tech Transfers of new products. The department supports the existing production facility but is also a huge part of the large expansion projects.

Main responsibilities

• Preparing, performing, and documenting commissioning, IQ, OQ and PQ activities
• Participating and executing change controls
• Planning and participation in projects with validation impact
• Planning, executing, and documenting all phases of cleaning validation.
• Preparation of validation planning/ reporting documents for product campaigns
• Writing and updating validation procedures and documents
• Participation in audits and inspections, answering regulatory requests.

Qualifications
You hold a Bachelor or higher degree in Engineering or other relevant discipline and have at least 3 years of relevant industry experience. You have demonstrated knowledge of industry practices, practical experience, and interest in hands-on validation execution.
You are conscious of lean ways of working and able to apply a risk-based approach to deliver efficient qualification. For this role you need to have strong technical writing and excellent communication skills, as you will have to articulate complex information to stakeholders such as Engineering, QC, QA, Manufacturing, Automation, Maintenance, etc.
You are a team player who enjoys working with colleagues and in cross-functional teams. As a person you bring a friendly, can-do behavior, professionalism, and a good sense of humor. You are independent and have a flexible, dynamic approach to work.

Your application
For more information about the open position, please contact Martin Therkelsen Validation Manger at +45 25663099 or Hanne Toft, Associate Director Validation at +45 23712992. 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