Validation Engineer for our Support Equipment team

Job title:

Validation Engineer for our Support Equipment team

Company:

Fujifilm

Job description

Are you ready to embark on a journey filled with innovative challenges in the field of validation? Join FUJIFILM Diosynth Biotechnologies (FDBD), a leader in Contract Development and Manufacturing, committed to excellence in our core areas of expertise.We are seeking a proficient Validation Engineer to bolster our team’s current expertise. This role demands experience in validating and documenting processes for autoclaves.About the Position

• Design, implement, and comprehensively document commissioning, IQ, OQ, and PQ activities for both new and existing support equipment.
• Develop and update Standard Operational Procedures (SOPs) to maintain compliance and efficiency.
• Provide support to the Engineering and Manufacturing departments on qualification and validation matters.
• Participate in audits and inspections, adeptly handling regulatory inquiries.
• Collaborate within cross-functional teams to facilitate process enhancements and change implementations.
• Engage with fellow Validation Engineers to share best practices and foster continuous improvement.

Qualifications

• Bachelor’s degree or higher in Engineering or a related field is preferred.
• A minimum of 3 years’ experience in validation processes for autoclaves is essential.
• In-depth understanding of industry practices and a strong track record in practical, hands-on validation execution.
• Awareness of lean methodologies, with the ability to apply risk-based approaches to achieve efficient qualifications.
• Exceptional technical writing and communication skills, essential for effectively conveying complex information to stakeholders such as Engineering, QC, QA, Manufacturing, Automation, and Maintenance.
• Demonstrated ability to work independently, while maintaining a flexible and adaptive workstyle.
• Proven experience in project management, with a well-structured and organized approach.
• Ability to work collaboratively in team settings, showcasing professionalism, a can-do attitude, and a positive demeanor.

About the Team
Become an integral member of our support equipment team, comprising 13 skilled professionals, a mix of dedicated consultants and full-time staff. Our team is responsible for the qualification and requalification of critical equipment such as autoclaves, glasswashers, and freezers, while providing essential support across diverse projects. Positioned within the Validation department, our team is tasked with sustaining the validated state of equipment within our expansive drug substance manufacturing facility. We support ongoing production operations and play a pivotal role in large-scale expansion initiatives.Your applicationIf you are driven by innovation and professional growth, we invite you to apply for a rewarding career with many development opportunities and the chance to work alongside highly competent and motivated colleagues.For more detailed information, please contact Claus Hellerøe, Manager for Support Equipment, at +45 31494229. We encourage you to submit your CV and cover letter in English at your earliest convenience, as we are conducting ongoing evaluations. The position will remain open until the ideal candidate is found.Working at FUJIFILM Diosynth BiotechnologiesWe 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.

Expected salary

Location

Hillerød, Hovedstaden

Job date

Sun, 09 Mar 2025 08:03:40 GMT

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