FUJIFILM - CQV Lead/ Project Manager

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

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.

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