Senior Process Validation Engineer

Kite Pharma - El Segundo, CA3.6

Full-timeEstimated: $100,000 - $130,000 a year
EducationSkills
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Job Description
Job Description

We are seeking a highly motivated individual to join us as a Senior Process 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.
Requirements:
  • 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
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