Amsterdam | Manufacturing Process Engineer | MES Specialist | EBR | GMP |1044965
Your new role
As Manufacturing Process Engineer (MES specialist) you will be joining the Manufacturing Technical Services (MTS) team. This team is responsible for manufacturing technical training, front-line support, root-cause investigations, continuous improvement and projects for Kite’s commercial manufacturing site producing autologous T-cell therapy products. This role is focused on MES but you will also have the opportunity to take part in other process engineering activities. Your general process engineering responsibilities include deploying, maintaining and implementing changes in computerised systems in manufacturing (MES, LIMS, ERP etc) and play a central role in the digitalisation of manufacturing in Kite.
Your main responsibilities will include but not limited to: Lead MES projects and change implementations, serve as part of the support group for MES users by analysing and resolving issues and providing the necessary instruction. Support EBR impact assessments. Create and update Process SOPs, MES SOPs and MES work instructions. Participate in audits as a MES subject matter expert. Covert processes and user requirements into specific EBR designs and design elements. Manage EBR approval and retirement workflows to ensure correct record state. Generate and maintain system life cycle documentation such as user requirements specifications, configuration specifications and functional / design specifications.
What you'll need to succeed
The ideal candidate will have a Bachelor’s degree or equivalent work experience. 5+ years of work experience within a pharmaceutical / GMP manufacturing site with a focus on process engineering or MES specialist. You should have excellent knowledge of the manufacturing process. Experience with writing and execution of CSV documentation and protocols. Experience with quality systems (change controls, deviations and CAPA’s) in a pharmaceutical environment. Knowledge of PAS -X version 3 is a plus. Experience with SQL and XML coding with respect to MES is a plus. Knowledge of the MES database and data elements as part of reporting is a plus. Experience with project management is preferred.
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.
With their brand-new production site in Hoofddorp and the R&D laboratories in Amsterdam, Kite is dreaming big. Now you can get the chance to be a part of this journey.
What you'll get in return
Hays Detachering | This is a project that will start with a contract for 6 months through Hays. Extension to stay within the department is 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. #1044965
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Wetenschap, Research & Development
Competitive Salary + Travel expenses covered
Spreek met een consultant
Spreek met Darren Noonan, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam