Responsible Engineer, Downstream Process Engineering - for Implementation of new processes

Now is the time to join our great team of Downstream Process Engineers! We are looking for a motivated, skilled team player who wants to make a difference every day.

Our team is growing as our site and capacity are expanding to support the manufacturing of biopharmaceuticals for our customers.

Your new role
This position has its primary focus on what we call tech transfer activities to ensure the downstream equipment readiness for the manufacture of future clinical and commercial products. In this role, you will be the main responsible for equipment modifications or implementation of new downstream equipment including driving the change management process. You will be the downstream equipment Subject Matter Expert (SME) in the overall tech transfer team, where your technical expertise will be needed for answering questions from our customers in addition to identifying the best technical solutions to ensure a successful tech transfer. Your tasks will also include performance of GAP analysis and reviewing the process flow diagrams.

The position interacts closely with several departments including the Drug Substance Manufacturing, Project Engineering, Quality, Automation, Validation, and Process Science.

The Downstream Process Engineering team also covers the daily support to the ongoing downstream production and support to larger projects including our current site expansion projects. However, regardless of individual responsibility, we support each other when needed and we strongly value collaboration and knowledge sharing. You will be part of a team that takes pride in delivering robust services and solutions to our stakeholders.

Responsibilities

• Act as Engineering SME providing support to the tech transfer team activities (Process review, customer interaction etc.)

• Scoping and implementation of equipment modifications

• Drive changes including performing risk assessments

• Support the production and secure reliable and robust operations

• Provide engineering technical troubleshooting for all purification equipment as required

• Review validation protocols and support commissioning and validation testing

• Perform training to ensure the production teams understand equipment functionalities

• Participation in the engineering on-call program is required on rotational basis

Skills & knowledge we hope you possess

• Minimum a Bachelor’s Degree within engineering or similar discipline

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

• Experience working with equipment in a commercial GMP environment is a big advantage

• Fluent in English both verbal and written

You’ll thrive in this role if you

• Enjoy working as part of a team and at the same time are comfortable working independently

• Are curios and have a strong sense of urgency

• Are self-driven and proactive

Your new team
In Downstream Process Engineering, we are approximately 25 individuals.

We are team players, entrepreneurs, and people who both like details and taking greater responsibility beyond our scope of work. The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

We look forward to helping you expand your skills in our fast-growing company

Your application
Has this sparked your interest, then please upload your CV and cover letter as soon as possible as we will screen candidates on a continuous basis and call in for interviews. Please do not hesitate to reach out to Director, Process Engineering, Cecilie Cederberg at e-mail: [email protected]

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