- Bachelor's Degree
- Master's Degree
- Microsoft Office
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
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.
- 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