Experienced Equipment Responsible Engineer for our Upstream Process

FUJIFILM Biotechnologies located in Hillerød, Denmark, is growing. Therefore, we have a new position open for an Equipment Responsible Engineer. In this role, you will provide vital support for clinical and commercial manufacturing of drug substance, and lead initiatives in quality, operational robustness, and cost savings, while ensuring compliance with cGMP, quality, and safety standards for FDA-regulated products.

About the Role

The primary responsibility of Upstream Process Engineering is to ensure the readiness and availability of upstream manufacturing equipment for operational needs. We are a dynamic team of Responsible Engineers (RE) with diverse backgrounds, experiences, and nationalities serving as the first contact for equipment issues, and we share an on-call telephone year-round. By nature, we rely on each other to resolve issues at all possible times of the day, and a good humor is essential for keeping the positive attitude strong.

This role will have particular focus on our core competencies within upstream process engineering, such as: bioreactors, SIP, CIP skids, centrifuges, feed vessels, and support equipment and processes. Also, the position interacts closely with the Drug Substance manufacturing team as well as several other engineering disciplines such as Quality, Automation, Validation, Process Science, Plant Engineering, Maintenance, and Project Engineering. In addition, this role will be center point for all activities such as maintenance, procurement of new equipment, assessment of instrument calibrations, as well as validation and manufacturing needs.

Responsibilities (not limited to)

Support the production and secure reliable and robust operations. Onsite support needs may occur in the evening and/or weekends and participation in the engineering on-call program is required on rotational basis.

Coordinate activities with immediate team members to support Daily Operations and expansion projects.

On-the-floor presence and support after any critical process equipment changes.

Support tech transfer activities of new processes from customers to the production site in Hillerød

Focus on operational robustness and cost efficiency in everyday work and processes.

Drive equipment changes, specify and install new equipment, provide engineering technical support and troubleshooting for all cell culture equipment as required.

Provide project engineering support as required for new processing equipment installations and modifications to existing equipment.

Participate in cross-functional teams to implement changes and / or improve existing processes.

Provide training as needed to ensure production team understands equipment functionalities.

Communicate progress, status, and issues to stakeholders and upper management.

Requirements

Minimum a bachelor’s degree within engineering (mechanical, chemical), biotechnology or similar discipline.

3+ years of experience in the areas of GMP manufacturing, engineering or facilities in a pharmaceutical environment.

Enjoy working as part of a team and being comfortable working independently.

Experience working with Cell Culture equipment in a commercial environment, particularly bioreactors, feed vessels and centrifuges.

Strong communication and problem-solving skills

Flexibility working outside normal business hours when needed

Fluent in English, both verbal and written.

Familiarity with computerized maintenance systems

About the area

Process Technology is a group of more than 100 employees that includes 5 departments: Automation, Process Engineering, Validation, Engineering Science and CAD services. We provide support to site-wide projects by offering our expertise as Automation, Process and Validation Engineers and we maintain overall responsibility for ensuring smooth daily operation including engineering technical leadership, and engineering technical support for all cell culture, purification, and pharmaceutical processing equipment.

The team consists of 8 responsible engineers. We value collaboration, knowledge sharing and take pride in delivering robust services and solutions to our stakeholders. We communicate openly, are inclusive and support each other every day regardless of individual responsibility.

On a person level our internal department workday is open, friendly, humorous, and relaxed. We create our own workday, and an individual and optimal work-life balance is highly prioritized. We meet with each other in social events and have the possibility to work from home, all dependent on nature of tasks and program.

Your application

If this sounds interesting to you, then we urge you to upload your resume and application as soon as possible, as we will be having interviews on an on-going basis until the right candidate has been found.

If you have any relevant questions, then please reach out to Apostolos Kaperonis Associate Manager, Process Engineering per e-mail: (available after 1st September) or Brian Seaby, Manager, Process Engineering per e-mail:

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.

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