Amsterdam | Equipment Validation | NPI | GMP | Tech Transfer | RCA | Quality Systems
Your new role
As Project Engineer you will be part of the technical team responsible for new technology implementation/facility expansion of our client’s commercial manufacturing site producing autologous T-cell therapy products. Your responsibilities will include giving your input on facility design and define equipment requirements as well as leading operational readiness for new delivered manufacturing areas and ensure the implantation of new equipment and processes. Documentation will include the drafting, review and approval of operation documentation as well as the review of IOQ and PQ documentation. You will conduct technical training and guidance to Cell Therapy Specialists and investigate and coordinate the resolution of exceptional deviations through comprehensive use of Root Cause Analysis tools. Finally, you will coordinate between internal stakeholders; manufacturing shop floor, facilities and engineering, quality assurance, quality engineers, MSAT and other project team members.
What you'll need to succeed
You have broad technical knowledge of cGMP compliance and experience with leading investigations, writing deviation reports, change controls and corrective actions. A minimum of 7 years of experience, preferably relating to cell culture, new equipment implementations and/or aseptic processes. You have previous experience with equipment and process validation. Proficiency related to quality systems such as agile, veeva vault or trackwise is preferred. The ability to think critically in a fast paced and expanding company with the ability to collaborate effectively between a wide range of different teams.
Your new company
Kite, a Gilead company, is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. Kite has been at the forefront of cancer immunotherapy and today are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. With an unrelenting drive and a singular focus on cell therapy, our team is executing on our strategy to bring life-saving therapies to patients.
What you'll get in return
Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension to stay within the department is highly anticipated. At this position, you will get a competitive salary and your travel expenses are covered.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1045469
Scientific and R&D
Competitive Salary + Travel expenses covered
Talk to a consultant
Talk to Tom Murphy, the specialist consultant managing this position, located in Amsterdam