Validation engineer for our Support Equipment team

Are you looking for new and exciting challenges within validation and 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 (FDBD), a biotech company that aspires to be the leading CDMO within our areas of expertise.

We are looking for a Validation Engineer who will complement the team’s current skills and with experience in below listed areas:

• Performing and documenting Qualification/validation of autoclaves and Part Washers
• Routine Cleaning monitoring of Part washers
• Assessments of loads for Part washers
• Perform requalification on assemblies in autoclaves and Part washers

About the team
You will become part of the support equipment team, which consists of 8 great colleagues who are a mixture of consultants and full-time employees. We qualify and requalify equipment such as autoclaves, glasswashers, and freezers, and we support in projects.

The support equipment team is part of a Validation department that is responsible for maintaining the validated state of equipment within the large-scale manufacturing drug substance facility. The department supports the existing production facility but is also a huge part of the large expansion projects. Validation is part of a global organization and there is responsibility for aligning between the sites.

About the position

• Planning, Preparing, performing, and documenting commissioning, IQ, OQ and PQ activities on new and existing support equipment.
• Write and update standard operational procedures.
• Support the Engineering department and Manufacturing in qualification and validation related topics
• Participation in audits and inspections, answering regulatory requests
• Participate in cross-functional teams to implement changes and/ or improve existing processes
• Collaborate with other validation Engineers (Internal) to share best practices and continues improvements

Qualifications

• You hold a Bachelor or a higher degree in Engineering or other relevant discipline.
• You have at least 3 years of experience working with Qualification/validation of Part washers and Autoclaves
• 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.
• You are independent and have a flexible, dynamic approach to work
• As a person you bring a friendly, can-do behavior, professionalism, and a good sense of humor.

If you can see yourself in this role, then we can offer an exciting and challenging job in a company with a very exciting future with many new partners and products and great possibilities for personal development. Just as importantly, you will join a great team of very competent and engaged employees with high spirits.

Your application
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.

For more information about the open position, please contact Claus Hellerøe, Manager for Support equipment at +45 3149 4229.

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