Equipment Engineer

Everyone at Kite is grounded by one goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

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 Equipment Engineer supporting our manufacturing facility in Frederick, MD. In this role, you will be a key contributor to the operation of our MFG organization

• Equipment Engineer supporting the licensure and operation of a fully automated cell therapy manufacturing facility
• Evolving Subject Matter Expert for cell therapy QC analytical, QC micro and MFG process equipment.
• Responsible for developing and maintaining Asset Life Cycle Management, including equipment records, spare parts lists, maintenance and calibration plans.
• Specify procure and install new assets into the facility.  Modify facility as needed to support new assets including space planning and utility planning.
• Support investigation and identify root cause for critical equipment and determine CAPA
• Participate in evaluation of new technology and automation for introduction into the Quality Control labs and MFG suites to improve efficiency, reliability and reduce cost.
• Work with vendors and corporate to define equipment requirements
• Write and review technical documentation (batch records, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, comparability, aseptic process and cell therapy manufacturing process validation testing)
• Executes change control and change management including cost and change justification
• Run Capital Projects supporting increased infrastructure and capacity
• May coordinate contract personnel through completion of assignments

• MS Degree and 5+ years’ experience in cGMP commercial manufacturing and regulatory requirements OR
• BS Degree and 7+ years’ experience in cGMP commercial manufacturing and regulatory requirements OR
• High School Degree and 11+ years’ experience in cGMP commercial manufacturing and regulatory requirements

• Understanding of basic engineering principles
• Degree in Biochemical Engineering, Chemical Engineering, or Biotechnology
• Experience with QC analytical and microbial equipment for a commercial cell therapy manufacturing facility
• Demonstrated troubleshooting and problem-solving skills with GMP process equipment and QC equipment
• Data trending and analysis for GMP process equipment and QC equipment
• Previous experience with cell therapy products is a plus
• Understands and employs principles and concepts of Lean Six Sigma to improve process capability
• Evolving knowledge of commercial manufacturing of biotechnology products, aseptic processing, cell therapy production
• Ability to generate, read and interpret drawings such as PFDs, floor plans, P&IDs and electrical schematics
• Excellent interpersonal, verbal and written communication skills
• Eager to rapidly learn and apply problem solving skills to new situations
• Self-motivated and willing to accept responsibilities outside of initial job description
• Well-developed computer skills

Does this sound like you? If so, please apply today!

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.