Senior Manager, Validation Engineering
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.
The Senior Manager, Validation is responsible for managing and leading all validation efforts at the El Segundo Cell Therapy Manufacturing facility, including the development and maintenance of the site Validation Master Plan. The role includes managing people, providing quality and technical direction to cross-functional teams, and actively participating in driving and developing strategies for continuous improvement of the engineering/facilities/validation quality systems. Responsibilities include all respects of the validation process, including developing and performing qualification studies to document evidence to ensure that equipment and processes will satisfactorily meet the client and facility specifications for quality. Performs the qualification and validation of equipment, facilities, utilities and systems. Assists in equipment selection, specification, and the application of a risk-based approach when determining qualification strategies. Works on complex problems in which analysis of situation or data requires an evaluation of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
Key Job Responsibilities:
- Ensuring a robust quality system is in place for the facility, to include: equipment & lab instruments; utilities, engineering, maintenance, computerized systems and validation activities.
- Ensure validation protocols and processes comply with global regulatory requirements.
- Correctly employ industry best practices that will successfully withstand regulatory inspections by regulatory authorities.
- Provide Validation oversight of change control for manufacturing systems, including facility and equipment projects.
- Provide Validation oversight of equipment, facility and utility qualification, computer system validation, cleaning validation, and shipping validation.
- Compose process validation, cleaning validation and process optimization protocols.
- Clearly and accurately document activities.
- Identify specific parameters, sampling and tests used in the validation protocols of new and existing products.
- Serves as information resource for validation technicians, contractors and vendors.
- Provide input to batch records.
- Monitor manufacturing processes during production to assess any technical process issues.
- Lead investigations and complete CAPA assignments.
- Performs other duties as assigned.
Essential Job Requirements:
- Minimum requirements include a Bachelor's degree in a technical, preferably an engineering or biological science discipline and 8-10 years pharmaceutical and/or biopharmaceutical industry experience OR MS degree in a technical, preferably an engineering or biological science discipline with 4 years’ experience in a pharmaceutical and/or biopharmaceutical industry experience.
- An advanced degree or additional industry certification is a plus.
- Experience validating equipment & lab instruments; utilities, engineering, maintenance, computerized systems and validation activities in a GMP environment
- Experience leading a team