Validation Engineer III

Job Description

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 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, Validation.

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 (like periodic reviews, revalidations, etc).
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 needed

Basic Qualifications:

Master’s degree with 3+ years of experience in Engineering in biotech/pharma industry OR

Bachelor’s degree with 5+ years of experience in Engineering in biotech/pharma industry OR

AA degree with 7+ years of experience in Engineering in biotech/pharma industry OR

High School degree with 9+ years of experience in Engineering in biotech/pharma industry

Preferred Qualifications:

Working knowledge of the validation role inside a cGMP manufacturing; a history of working inside the regulations and requirements for biologics, pharmaceuticals and medical devices.

Be able to read and interpret drawings such as blueprints, PFDs, P&IDs.

Working knowledge of scientific and engineering principles in the biopharmaceutical industry.

Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) for process and utility equipment.

Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, and process development.

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.

Ability to use AutoCAD, read PLC logic, and better if you know how to use common PLC programming software.

Some experience with cell culture and better if it is with a cell therapy.

Some experience with process validation.