Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells.
Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.
We are on a rapid growth trajectory and have a highly energized and accomplished team.
We are seeking a highly motivated individual to join us as an Engineer II Validation Engineer.
Responsibilities (include but are not limited to) :
Creation and execution of 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 and implement corrective actions related to CAPAs and deviations.
Develop technical specifications.
Support the execution of engineering projects.
Other duties as assigned.
BS or MS degree in Biochemical Engineering, Chemical Engineering, Mechanical Engineering, Biotechnology or Life Sciences with 4+ 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 is a plus
Read and interpret drawings such as PFDs, P&IDs and electrical schematics.
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development.
Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions.
Ability to think critically, and demonstrated troubleshooting and problem solving skills.
Ability to function efficiently and independently in a changing environment.
Self-motivated and willing to accept temporary responsibilities outside of initial job description.
Well-developed computer skills and fluent with Microsoft office applications.
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-
term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow KitePharma on Twitter at www.twitter.com / kitepharma.