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Engineering Specialist - United States  

Kite Pharma (company)


Posted on : 14 April 2017

Project Description

  • Our company  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. 
  •  We are seeking a highly motivated individual to join us as an Engineering Specialist.  
  • 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 resource reporting to the Sr. Manager Facilities & Engineering.

Responsibilities (include but are not limited to):
  • Perform development and implementation of new equipment technologies 
  • Analyze equipment/processes and identify the areas that needs improvement. 
  • Provide guidance during planning, designing and development of projects. 
  • Write and review technical documentation (development reports, SOPs, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, and validation testing) 
  • Perform investigations and implement corrective actions 
  • Creation, execution of Test Protocols (IOQ / PQ), including identification and resolution of non-conformances/deviations. 
  • Perform temperature mapping and other miscellaneous validation activities. 
  • Manage contractors performing equipment qualifications. 
  • Report status and progress of qualification activities or projects to the Leadership team. 
  • Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues 
  • Develop technical specifications 
  • Execute projects as required 
  • Other duties as assigned 

  • BS or MS degree in Biochemical Engineering, Chemical Engineering, Mechanical Engineering, Biotechnology or equivalent with 12+ years of experience.  Engineering degree required. 
  • Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics, pharmaceuticals and medical devices 
  • Cell culture experience 
  • Read and interpret drawings such as blueprints, PFDs, P&IDs, AutoCAD, PLC 
  • Working knowledge of scientific and engineering principles 
  • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is preferred; process validation experience is a plus 
  • 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 
  • 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 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 

About Us:
  • Our company is an equal opportunity employer.
  • We are able to offer the opportunity to be part of the first 200 employees in this successful, fast growing company.  
  • A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.