Responsible Engineer for our Upstream Process Engineering area
FUJIFILM Biotechnologies
Dato: for 1 dag siden
By: Hillerød, Region Hovedstaden
Kontrakttype: Fuld tid
FUJIFILM Biotechnologies in Hillerød, Denmark, is seeking a dedicated Responsible Engineer for our expanding Upstream Process Engineering area. Be part of our innovative team, contributing to manufacturing while supporting initiatives for improvements, operational robustness, and cost efficiency.
Become a vital part of our mission to deliver excellence in pharmaceutical manufacturing. Join a team that thrives on innovation, teamwork, and making impactful contributions.
The role
In this role, you will provide crucial support for clinical and commercial manufacturing of drug substance, improvements, quality/operational robustness/cost savings initiatives while ensuring compliance with cGMP, quality and safety standards for FDA regulated products.
In the beginning you will be part of the project engineering team during construction of one of our new production facilities. Here you will support the process engineering team with vessel and skid vendor management and commissioning work when equipment is coming to site.
Later your job will transform to be part of the Upstream Process Engineering team which is in the Engineering Support department.
The overall responsibility of Upstream Process Engineering is to secure that the upstream manufacturing equipment is available for manufacturing when needed.
The position interacts closely with the Drug Substance manufacturing team as well as several engineering disciplines such as Quality, Automation, Validation, Process Science, Plant Engineering, Maintenance, and Project Engineering.
Responsibilities During Construction
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.
Application
If you can see yourself in this role, then we urge you to apply.
In case of any questions, please reach out to Asbjørn Thorvildsen per email: Asbjørn Thorvildsen [email protected]
Due to summer holidays, please know that applications will be reviewed from August just as interviews are expected to begin in August.
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 (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.
Become a vital part of our mission to deliver excellence in pharmaceutical manufacturing. Join a team that thrives on innovation, teamwork, and making impactful contributions.
The role
In this role, you will provide crucial support for clinical and commercial manufacturing of drug substance, improvements, quality/operational robustness/cost savings initiatives while ensuring compliance with cGMP, quality and safety standards for FDA regulated products.
In the beginning you will be part of the project engineering team during construction of one of our new production facilities. Here you will support the process engineering team with vessel and skid vendor management and commissioning work when equipment is coming to site.
Later your job will transform to be part of the Upstream Process Engineering team which is in the Engineering Support department.
The overall responsibility of Upstream Process Engineering is to secure that the upstream manufacturing equipment is available for manufacturing when needed.
The position interacts closely with the Drug Substance manufacturing team as well as several engineering disciplines such as Quality, Automation, Validation, Process Science, Plant Engineering, Maintenance, and Project Engineering.
Responsibilities During Construction
- Support OQ/PQ activities
- SAT activities
- Support construction work on-site
- 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.
- 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, support, and perform assessment based on impact and effort for prioritization.
- Drives equipment changes, specify and install new equipment, provides engineering technical support and troubleshooting for all cell culture equipment as required.
- Review validation protocols and supports validation testing.
- Provides 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.
- 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.
- Enjoy working as part of a team and also being comfortable working independently.
- Experience working with Cell Culture equipment in a commercial environment is a big advantage.
- Fluent in English both verbal and written.
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.
Application
If you can see yourself in this role, then we urge you to apply.
In case of any questions, please reach out to Asbjørn Thorvildsen per email: Asbjørn Thorvildsen [email protected]
Due to summer holidays, please know that applications will be reviewed from August just as interviews are expected to begin in August.
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 (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.
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