
Validation Engineer
Netherlands - HoofddorpFacilities Operations/EH&SRegularJob Description
As Validation Engineer you will work with the Engineering and Manufacturing teams in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on role reporting to the Senior Manager, Engineering.
Kite, A Gilead Company
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
Your responsibilities
- Create and execute qualification protocols (IOQ / PQ), including identification and resolution of non-conformances/deviations
- Provide equipment, system and facility qualification guidance and strategy during project planning and development phases
- Oversee and manage validation instrument inventory including calibrations
- Review technical documentation including protocols & summary reports for IOQ / PQ testing, and validation SOPs
- Perform temperature mapping and other miscellaneous validation activities
- Manage contractors performing equipment and system qualifications
- Report status and progress of qualification activities or projects to the Leadership team.
- Perform investigations, create deviations, and implement preventative and corrective actions related to CAPAs
- Develop technical specifications
- Support the execution of engineering projects
- Other duties as assigned
Your profile:
- Bachelor / Master degree in Biochemical Engineering, Chemical, Electrical, or Mechanical Engineering, Biotechnology or Life Sciences with several years of validation experience in the biotechnology, pharmaceutical or medical device industry. Engineering degree is preferred.
- Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biotechnology, pharmaceuticals and medical devices
- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is essential; utility and facility validation experience is strongly preferred; process validation experience and/or CQV is considered a plus
- Read and interpret drawings such as PFDs, P&IDs and electrical schematics
- Working knowledge of scientific and engineering principles related to the bio-pharmaceutical industry
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products and/or aseptic processing, cell therapy products, or process development
- Computer literate, efficient with Microsoft office applications and with technical software applications
- Ability to think critically with demonstrated troubleshooting and problem-solving skills
- Excellent interpersonal, verbal and written communication skills are essential in our collaborative work environment
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities
- Self-motivated and willing to accept temporary responsibilities outside of the initial job description
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards eliminating the burden of chronic cancer care, don’t miss out on this opportunity to join us.
Only candidates in possession of a valid EU work permit will be considered.