Facilities | El Segundo, CA | Full Time
Kite Pharma, Inc., 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.
We are seeking a highly motivated individual to join us as a Validation Engineer. 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, Engineering.
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 10+ 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
- Cell culture experience is preferred.
- Read and interpret drawings such as PFDs, P&IDs and electrical schematics.
- Working knowledge of scientific and engineering principles related to the bio
- 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
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.