Amsterdam | Process Engineer | Cell Therapy | GMP | Tech Transfer | Development | Process Validation | 1044961
Your new role
We are actively searching for a highly affective Process Engineer. The successful candidate will work closely Process Development teams to ensue process reliability and robustness in preparation for comparability and process validation. You will also participate and support process FMEAs to understand process and product risk as a pre-requisite for process validation. Participate in evaluation of new technology and process automation for introduction into GMP manufacturing. Work with vendors and suppliers to define requirements and understand functional specifications. Support investigation identify root cause for critical deviations to maintain routine manufacturing operations and determine CAPAs for manufacturing. The successful candidate will also be involved in writing and reviewing technical documentation for e.g. batch records, SOPs, protocols & reports for equipment qualification, comparability, process and cell therapy manufacturing process validation testing. You will also participate and report to a cross-functional development team to advance production activities. In addition you will also ensure successful manufacturing process comparability and process validation runs. Finally, participate in laboratory experiments that support process development for extended process characterisation, investigation resolution and process improvements.
What you'll need to succeed
Do you have a BSc degree in Life Science, Biotechnology or in a related field with 3+ years of experience in a pharmaceutical environment, preferably in cell therapy? We are looking for someone with a strong background in technical documentation with experience in CAPAs and root cause analysis. In addition, we would like this person to have experience working with Quality Systems. Experience with tech transfer is strongly 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 12 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. #1044961
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Wetenschap, Research & Development
Competitive Salary + Travel Expenses covered
Spreek met een consultant
Spreek met Eibhlin Hanlon, de recruiting expert die deze vacature in behandeling heeft, werkzaam in kantoor Amsterdam