CQV Lead/ Project Manager, Hillerød, Denmark

Do you want to join an advanced biotech company that develops and manufactures some of the leading biological products on the market today and for the future? Then join FUJIFILM Diosynth Biotechnologies (FDB), a biotech company that aspires to be the leading CDMO within our areas of expertise.

We are looking for an experienced Commissioning, Qualification and Validation (CQV) lead/ project manager to join our Hillerød Validation Engineering team.

About the department

The validation team is part of Process Engineering and Validation department. The team is responsibility for maintaining the validated state of equipment within the large scale manufacturing drug substance facility. This includes qualification of new equipment, chamber validation, cleaning validation, and participation in projects/changes. The department is supporting the existing production facility but is also part of the large expansion project, where we are doubling the current production capacity. The department will over the coming years grow to match the increased production capacity.

The team you join and your role

The first couple of years you will be part of the drug substance part, of the on-going expansion project on Site Hillerød. Here you will work in the large CQV organization together with internal and external colleagues. The project is in the execution phase, where the new equipment will arrive on site during 2022 and 2023. In the project you will get the responsibility for the C&Q activities for a package of equipment. When the project is finalized you will return to the Validation department as CQV PM on larger equipment changes in the production or tech transfers.

Main responsibilities

• Project manager for CQV activities in projects, responsible for time schedules in according to project plan, secure the right manning and follow up.
• Responsible for the Qualification/Validation level in projects are aligned with the site level for facility, utility, and equipment before hand-over to LoB.
• Secure alignment between projects and existing operations CQV approach
• Support implementing risk based CQV in existing production
• Collaborate with other CQV leads/ project managers (Internal and on other FDB sites) to share best practices and continues align and improve Global CQV concept.
• Write validation master planes, quality risk assessments and other CQV related documents.

The successful candidate will

• Possess experience in managing the CQV track of a large scale capacity increase project.
• Have up to date knowledge of requirements for equipment qualification and cleaning validation
• Have a good general understanding of drug substance manufacturing. Preferable from multi product production line and facilities.
• Experience in writing and review validation master planes, quality risk assessments and other CQV related documents.
• Experience with risk based CQV approach, based on ASTM E2500
• Have excellent communication/ presentations skills and be able to articulate complex information to management and support functions (QA, Engineering, Automation and other.)
• Be a team player who works well with colleagues and cross-functional.

You hold a bachelor’s or higher degree in a relevant discipline and have at least 5 years of relevant industry experience from drug substance manufacturing and at least 3 years of project manager experience, preferable form a CQV lead role. You are self-starting and have a flexible, dynamic approach to work. You bring a friendly, can-do demeanor, professionalism, and a good sense of humor.

For more information about the open position, please contact Hanne Toft, Sr. Manager Validation at +45 23712992.

Please upload your CV and cover letter in English as soon as possible as we screen candidates on a continuous basis:

https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/CQV-Lead_JR914

The Job Ad will be removed when the right candidate has been identified.

About FUJIFILM Diosynth Biotechnologies

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 site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

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.

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.

www.fujifilmdiosynth.com


Kilde: Jobnet.dk