Subject Matter Expert in GMP and Facility Management

As part of our ongoing expansion, we are seeking a highly motivated and experienced  Subject Matter Expert (SME) specialized in Good Manufacturing Practices (GMP) and facility management.

Role and Team Overview:

You will join our dynamic Facility Group, comprised of 15 skilled professionals, each excelling in their respective fields. Our department covers a range of responsibilities including facility maintenance,  gowning, cleaning services, pest control, and strategic facility projects.

We aim to find an experienced cGMP SME who excels at managing multiple projects and tasks within the Facility team. This position is an integral part of our growth strategy, where your role will be to collaborate closely with the Facility Management team, internal stakeholders, and outsourced service partners to facilitate site expansion while maintaining production standards. Your role will include serving as a Facility Management SME and change owner across various site functions.

Your Profile:

You are passionate about being part of a growing company with ambitious goals centered on patient care, people, and quality. Your role demands high degree of self-management skills, with opportunities for remote work when on-site presence is unnecessary. Our Facility Management and Security department is a key component of Engineering & Operations Support (EOS) organization at FDBD, dedicated to providing outstanding service and fostering a 'best place to work' culture. Collaboration across the entire site is essential.

Work Environment:

Our department encourages an open, friendly, and relaxed work atmosphere, emphasizing humor and flexibility. We prioritize individual work-life balance and facilitate social events, with opportunities for remote work dependent on task demands and schedules.

Key Responsibilities:

• Drive facility-related changes, CAPA and deviations
• Develop and refine facility procedures.
• Participate in audit and inspections
• Participate in Continuous  improvement projects within the Facility Management area

Requirements:

The ideal candidate will possess the following:

• Experience with electronic document systems.
• Proven experience in a cGMP facility environment.
• Strong communication skills with fluency in English.
• Passion and aptitude for process optimization.
• Self-motivation and a flexible, dynamic approach to work.
• A commitment to team success, coupled with high performance and ambition.

We invite qualified candidates who are eager to contribute to a vibrant and expanding organization to apply for this pivotal role.

Application

Has this sparked your interest? Then we want you to apply as soon as possible. We will continuously invite relevant candidates for job interviews and will close the job post as soon as we have found the right candidate.

What we offer

The exciting 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 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 site in Hillerød, Denmark, brings together expertise, capabilities, and technologies to manufacture advanced biologics. The large-scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

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.

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.