Are you looking for new and exciting challenges within Validation?
Join Fujifilm Biotechnologies in Hillerød as we expand to support our growing number of equipment and systems. We are looking for Validation Engineers who share our passion, drive, and energy to join our team.
We're seeking a Validation Engineer to enhance our team’s skills with experience in one or more of the following areas:
- Qualification/Validation of upstream process equipment
- Cleaning validation
- Tech transfer of new products
Main Responsibilities
As part of the Validation team, you will participate in tech transfers of new products in our ongoing production. You will perform qualifications and cleaning validations of new equipment or modifications and prepare the associated protocols and reports.
Additional Tasks (include but are not limited to):
- Prepare, plan, perform, and document VPP, IQ, OQ, and PQ activities
- Participate in and assess change controls, executing various actions
- Plan and participate in key projects with validation impact
- Plan, prepare, execute, and document all phases of cleaning validation
- Write and update validation procedures and technical documents
- Participate in audits, inspections, and respond to regulatory requests
Qualifications
Professionally
- You hold a Bachelor's degree (or higher) in Engineering or a relevant discipline.
- At least 3 years of industry experience.
- You possess knowledge of industry practice, practical experience, and you have a keen interest in hands-on validation execution.
- You are aware of lean working methods and can apply a risk-based approach to deliver efficient qualifications.
- Strong technical writing and excellent communication skills are essential, as you will need to articulate complex information to stakeholders such as Engineering, QC, QA, Manufacturing, Automation, Maintenance, and Process Science.
Personally
- You are a team player who thrives in collaboration and cross-functional teams.
- You bring a friendly, can-do attitude, professionalism, and a good sense of humor.
- You are independent, adaptable, and have a dynamic approach to work.
About the department and the team
The Validation team has the responsibility of ensuring the validated state of the running production systems within the large-scale manufacturing drug substance facility. The team is divided in upstream and downstream, and they participate in tech transfer of products, qualification of new equipment and modifications as well as in larger projects.
We have good sense of humor in the team, and we are good at helping each other. We are good at integrating new hires into the team and give a thorough introduction to our systems. There are also a lot of social events within the department.
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, but due to summer holidays, it's expected to start interviewing around August.
For more information about the open position, please contact Martin Therkelsen, Manager Validation at +45 2566 3099.
Working at FUJIFILM 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 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 Biotechnologies Denmark 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.