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Can you see yourself as being a part of a successful team of Quality Control (QC) professionals during times of change and new opportunities? We invite you to join a global pharma company with a strong local presence and an exciting future.
We are looking for a skilled QC Environmental Monitoring Scientist to join our QC Microbiology team
As a scientist for Environmental Monitoring, you will have a vital role in a very exciting time for the organization as the branch in Hillerød is currently in the process of expanding Drug Product (DP), expanding the Drug Substance (DS) and Finished Goods (FG) capabilities as a Contract Development and Manufacturing Organization (CDMO).
Would you like to improve how we support and conduct monitoring and reporting activities to ensuring that the production environment is in top shape?
Do you get excited when a Facility qualification is coming up?
Then this might be your next job.
You will be part of a world-class GMP manufacturing facility, and a leading CDMO where we advance tomorrow’s medicines today.
About FUJIFILM Diosynth Biotechnologies and our Quality Control Department
FUJIFILM Diosynth Biotechnologies is a world leading Contract Development Manufacturing Organization (CDMO) serving customers in the pharmaceutical industry – from pre-clinical investigations to commercial GMP production. Our overall mission is to “Advancing Tomorrow’s Medicines” and we like to invite you to be part of that journey.
Our Quality Control (QC) department at site Hillerød consists of approximately 200 employees divided into different support teams and five testing teams. In QC we strive towards a OneQC team spirit where we help and support each other across teams not only to reach our goals but also to support a high level of collaboration and possibilities for personal development. The pillar in our QC department is our employees – our success is only possible due to competent and dedicated colleagues, who wants to make a difference for QC, our site, our customers, and patients all over the globe. As a leading CDMO company we, in QC, are obligated to continuously improve our way of working creating a dynamic and inspiring environment with huge individual co-decision making due to our flat organizational structure.
The culture at FUJIFILM Denmark (FDBD) is key if you ask our employees and besides a competitive salary and bonus package, we offer health insurance, massage and physiotherapy, health check, fitness center, possibility to work from home and most recently we invested in a mobile barista coffee van. FDBD also has a canteen arrangement incl. Friday brunch and monthly afternoon cake, just as we have a “bell ringing” tradition when reaching important milestones.
About the position
When working at FUJIFILM Diosynth Biotechnologies Denmark you will, besides from the tasks listed below, onboard new customers and products to the site, build a network across QC and FDBD, support our site expansion project, and assist in finding new and innovative ways of working smarter in a complex everyday life.
Your primary tasks will be but not limited to:
- Be part of a team working on new Filling line in our new Drug Product Manufacturing (DPM) area.
- Lead and support EM OQ and PQ activities in relation to DPM Expansion and DPM projects.
- Making and assessing change controls for various processes & projects that needs to be implemented.
- Handle Alert & Action Level EM Excursions.
- Handle Deviations. Knowledge of A3 investigation tool is an advantage.
- Elaborate EM and UM Trend reports.
- Present EM and UM Trend for Management and Designated Representatives from other departments on site.
- Present EM and UM subjects at Inspection/Audits.
- Coordination and harmonization of EM and UM program acc. to cGMP.
- Elaboration and maintenance of EM Risk Assessments based on FMEA principles.
- Support and participate in the daily business.
About the teams
Microbiology in QC currently consists of 46 dedicated employees – scientists, laboratory technicians, samplers, student helpers and four associate managers. The teams deliver very important results that support the final release of the Drug Substance batch – and hence the bioburden samples are tested within 24 hours. The teams support 7 days a week testing within normal working hours.
The teams enjoy working within the field and are very engaged and knowledgeable. They have a great team spirit approach when it comes to making sure the laboratory runs smoothly and results are delivered within timelines.
The atmosphere at work is informal and fun. You can count of support from your colleagues when standing on a burning platform. The culture is unique, and you can count on a friendly network across departments, which add to our productivity and strong connections. Our focus on our principle of “Best Place to work” means for example that we have a high degree of flexibility adding a good balance between work and private life.
Professional and Personal Qualifications
- You have an academic background such as chemical or process engineer, pharmacist, biologist, microbiologist or similar within Environment Monitoring.
- Experience with aseptic production & support.
- Previous experience working within QC or with GXP or quality systems is an advantage.
- Knowledge of Annex I is an advantage.
We are looking for a person who has a can-do-attitude and energy and who understands the requirements of a cGMP QC Environment Monitoring team. Someone who can handle a busy environment with many changing priorities without losing your good mood and overview. As a person you possess excellent collaboration skills and understand the need for working closely together in the team – helping each other deliver on common goals. You are curious, self-driven, dedicated, and systematic and can plan your day in a structured way. You appreciate a team where there is room for technical discussions as well as a good laugh. Fluency in English is required as English is our corporate language.
If you can see yourself in this role, then we can offer an exciting and challenging job in a company with a very exciting future with many new partners and products and great possibilities for personal development and responsibility. Just as important you will join a great team of very competent and engaged employees full of humor and great team spirit. In our dynamic daily operation, we put people first and always strive to ensure an interesting and developing work environment #BestPlacetoWork.
Application
Has this sparked your interest? Then we urge you to send an updated CV and cover letter as soon as possible and latest by 15th of August. We will continuously invite relevant candidates for job interviews and will close the position as soon as we have found the right candidate.
In case you have any questions, please do not hesitate to reach out at:
fdbdqcmicrobiologymanagers@fujifilm.com
About FUJIFILM Diosynth Biotechnologies
We are 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.
We are 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. Learn more at
https://fujifilmdiosynth.com/
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.
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