Senior Equipment Engineer

Employer
Kite Pharma
Location
Frederick, MD, United States
Posted
Nov 22, 2020
Ref
R0016187
Required Education
Doctorate/PHD/MD
Position Type
Full time
Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

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

Key responsibilities:
  • Equipment Engineer supporting the start-up and licensure of a fully automated cell therapy green field manufacturing facility
  • Subject Matter Expert for cell therapy process equipment and clean rooms
  • Responsible for developing and maintaining equipment records, spare parts lists, maintenance and calibration plans.
  • Participate in evaluation of new technology and process automation for introduction into GMP manufacturing including optimizing single use components for system closure
  • Work with vendors and process development to define equipment requirements
  • Interact with the automation team to develop fully automate the MFG process with integration to Electronic Batch Records
  • Execute design, procurement, C&Q, and PPQ batches to license the facility
  • 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)
  • Support investigation, identify root cause for critical deviations during process validation, and determine CAPA for manufacturing
  • Executes change control and change management including cost and change justification during startup and C&Q activities
  • May coordinate contract personnel through completion of assignments; may provide guidance to other engineers.


Basic Qualifications:
  • Master's Degree and 5+ years' experience in cGMP commercial manufacturing and regulatory requirements OR
  • Bachelor's 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


Preferred Qualifications:
  • Mastery of engineering principles
  • Degree in Biochemical Engineering, Chemical Engineering, Biotechnology
  • Experience with clean rooms, HVAC, ISO standards, and utilities supporting cGMP manufacturing
  • Cell culture or aseptic processing experience
  • Previous experience with cell therapy products
  • Understands and employs principles and concepts of Lean Six Sigma to improve process capability
  • Demonstrated knowledge of pharmaceutical 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
  • Working knowledge of instrumentation and controls, as well as PLCs and DCS
  • Ability to think critically, and demonstrated troubleshooting and problem solving skills
  • Excellent interpersonal, verbal and written communication 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


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.

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For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.