Responsible Engineer / Filling Expert for our Aseptic Filling Line in Drug Product Manufacturing

Are you looking for an opportunity to join a growing pharmaceutical organization at a pivotal moment?
At FUJIFILM Biotechnologies Denmark in Hillerød, we are entering an exciting phase where our Drug Product Manufacturing Facility is coming into operation.
You now have the chance to be a part of this journey and play a central role in the Drug Product MSAT team, as we are currently looking for a Responsible Engineer/ Filling SME to strengthen our team.
 

The job
By assuming the technical ownership of the aseptic filling equipment, this is a high visibility role with high impact on the Drug Product organization as both operational and tactical levels.
The Responsible Engineer/ Aseptic Filling SME has 3 major accountabilities:

• Achieve and maintain validated state of the Filling Line and format parts (along with CQV)
• Monitor and improve Equipment performance (periodic reviews, OEEs, spare parts burn rate and drive improvements projects)
• Act as Aseptic Filling SME in Tech Transfer projects and provide Level 2 technical support for Operations (Support to major changes impacting product quality and critical process parameters)

Main tasks

• Assume technical ownership of Filling Equipment upon completion System release activities
• Develop and maintain equipment and processes documentation
• Build Filling Format parts strategy, overview for all programs. Accountable to develop operational procedures of handling format parts in DPM
• Accountable for performance of equipment (periodic reviews, OEEs, performance and improvements projects)
• Provide support to tech transfer programs and operations as equipment owner
• Responsible for driving and supporting GMP events related to equipment in scope such as deviations, change controls, events, inspections
• Participate in Operational board meetings and validation activities as well as act as technical support to GMP events when validated state is impacted
• Act as Second Line support for Filling equipment and process issues.
• Lead troubleshooting activities and take ownership of relevant Deviations and CAPAs Qualifications

Qualifications
Professionally

• Minimum 3y experience as engineer in GMP environment
• 2-3 years’ experience in Aseptic Filling equipment mandatory
• Knowledge of Validation and Risk Assessment of manufacturing equipment in GMP
• Knowledge of Annex 1,15, ASTM E2500, ICH Q9, Quality By Design appreciated

 
Personally

• Have a structured approach
• Have very strong interpersonal skills
• Value the team effort against individual performance
• Are solution oriented
• Display a positive attitude when facing challenges
  
   

Our team
DP MSAT covers a broad scope and plays a central part in Drug Product Manufacturing. Our team is composed of process owners, responsible engineers, technology specialists, CQV leads, and Pilot laboratory scientists.
We are a very diverse team at many levels and have an open & honest tone and approach to every day challenges.

The work environment is international and informal. We keep a high pace and focus on a vital work 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.


Your application
Has this sparked your interest, then please upload your CV and cover letter as soon as possible, as we screen candidates on a continuous basis and call in for interviews.

If you have any questions, reach out to the hiring manager Frédéric Osuch +45 2072 3569.

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.