Hiring company: Kite Pharma
Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs.
We are seeking a highly motivated Sr. Validation, Engineer to support our Oceanside, CA site.
Responsibilities
- Responsible for performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects. This includes developing validation master plans with minimum supervision, preparing protocols independently, analyzing test results, and preparing technical reports.
- Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature, to support clinical and commercial manufacturing.
- Coordinates validation activities with, and seeks team supports from, Validation, Development, Manufacturing, Engineering, Quality, third Parties, and other groups on validation projects to ensure validation projects are carried out on time and on budget.
- Coordinates the activities of assigned validation and contract personnel and ensures the quality of completed work.
- Reviews protocols, reports and data tables generated by peers and contract personnel.
- Represents the department on cross-functional project teams.
- As required, assists in preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine internal and pre-approval inspections.
Knowledge and Skills
- In-depth understanding and application of validation principles, concepts, practices, and standards.
- In-depth knowledge of current Good Manufacturing Practices (GMPs).
- Extensive working knowledge of equipment and systems.
- Extensive knowledge of industry practices.
- Excellent verbal, written, and interpersonal communication skills are required.
- Demonstrated investigation and report writing skills.
- Proficient in Microsoft Office applications.
- Proven analytical and conceptual skills.
Basic Qualifications
- Master’s degree with 6+ years of experience in facilities, engineering in a biotech/pharma industry Or
- Bachelor’s degree with 8+ years of experience in facilities, engineering in a biotech/pharma industry Or
- High School diploma with 12+ years of experience in facilities, engineering in a biotech/pharma industry
Preferred Qualifications
- 10+ years of relevant experience and a BS or BA or related fields
- Has previous experience in biotech or pharmaceuticals industry
- Has previous experience in validation in highly regulated manufacturing environments.
- Experience writing and executing commissioning and verification protocols and associated Validation documentation
- Regulatory Agency Experience is a must
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.