Facilities | El Segundo, CA | Full Time
Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California. Kite is 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. For more information on Kite, please visit www.kitepharma.com.
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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.
We are seeking a highly motivated individual to join us as a Specialist, Engineering. 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
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.