Senior Manufacturing Engineer

Amsterdam | MSc | 10+ years’ experience | Cell Therapy | GMP |Technical Support | 1044461

Your new role
The successful candidate will deliver engineering support to the maintenance team in relation to equipment, facilities or electrical installations while also providing technical input to implementation of projects. In addition, you will also manage electrical projects relating to the area of specialisation. This involves providing advanced engineering support to ongoing activities and projects acting as a specialist advisor across the Engineering function. Furthermore, you will be responsible for the execution of facilities/equipment/utilities project, overseeing all facets including conceptual design, detailed design, installation and commissioning. Alongside this, you will define project scopes, prepare requests for proposal (RFPs), prepare cost estimates and provide justification for capital projects. Additional tasks can include, but not limited to:
  • Acting as engineering SME during planning, design and development of projects
  • Execute FATs and SATs
  • Write and provide technical review of documentation including commissioning and validation protocols, SOPs, Engineering drawings, functional test plans, User Requirements Specifications (URS), Functional Design Specifications (FDS), FATs and SATs
  • Manage contractors performing equipment, utility and facility work during project execution
  • Own or support Deviations and CAPAs, perform investigations, root-cause analysis and implement corrective actions
  • Perform risk assessments, system impact assessments and FMEAs
  • Own change control, write change control test plans and execute them
  • Support Validation execution activities as required, including resolving deviations
  • Coaching and mentoring junior engineers
  • Manage and coordinate resources across different teams

What you'll need to succeed
MSc with 10+ years of experience in engineering, manufacturing in the Biotech or Cell Therapy industry. 5+ years of experience with GMP in the pharmaceutical industry. Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals. Knowledge of cell culture or cell therapy manufacturing technical support. Experience writing and reviewing technical documentations such as commissioning and validation protocols. In addition, experience with deviations, CAPAs and root-cause analysis. Experience coaching and mentoring junior colleagues.

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. #1044461
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Job Type
Wetenschap, Research & Development
Life Sciences
Competitive Salary + Travel Expenses covered

Talk to a consultant

Talk to Eibhlin Hanlon, the specialist consultant managing this position, located in Amsterdam
Hays Amsterdam, H.J.E. Wenckebachweg 210

Telephone: 0615868143