Job DescriptionEveryone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission! We are seeking a highly effective Senior Validation Engineer responsible for planning, execution, and documentation of commissioning, qualification, and validation activities for manufacturing and Quality Control equipment, facilities, utilities, and related systems. The role requires extensive hands-on validation experience, including protocol authoring, field execution, data analysis, technical report generation, and support of digital validation processes through KNEAT and other validation systems.
Responsibilities (include but are not limited to):- Responsible for performing validation of manufacturing and Quality Control equipment, storage areas, utility systems, facilities, processes, and/or automation systems. This includes developing validation master plans with minimal supervision, preparing protocols independently, analyzing test results, and preparing technical reports.
- Develop, execute, and analyze temperature mapping and autoclave heat penetration studies to support equipment qualification and regulatory compliance.
- Lead validation projects through the development of validation schedules, master plans, protocols, reports, and related lifecycle documentation for systems supporting clinical and commercial manufacturing.
- Perform, lead, and document commissioning, qualification, validation, and temperature mapping activities for facilities, utilities, equipment, storage environments, and related systems in accordance with SOPs, cGMPs, and regulatory requirements.
- Serve as the KNEAT SME and power user, providing technical guidance, user support, process improvements, and expertise in the execution and management of digital validation records and workflows.
- 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 contract personnel and ensures the quality of completed work.
- Investigate validation deviations or failures, identify root causes, support corrective actions, and escalate technical or compliance risks as appropriate.
- Maintain compliant validation records and support data integrity, documentation quality, and lifecycle validation requirements.
- Provide technical guidance to validation technicians, junior staff, internal teams, contractors, and vendors.
- 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.
- Support occasional night, weekend, or off-shift work based on business needs.
- Additional duties as assigned.
Basic Qualifications:- Bachelor's degree in engineering, engineering technology, or related field with 7+ years of experience in equipment, facility, and utilities validation.
- Master's degree with 5+ years of experience in validation in a biotech/pharma industry
- Experience in GMP/cGMP-regulated environments
- Extensive hands-on experience developing, executing, and documenting commissioning, qualification, and validation activities, including protocol authoring, field execution, data analysis, deviation resolution, and report generation.
Preferred Qualifications:- Experience validating equipment, facilities, and utility systems within a GMP-regulated biotechnology or pharmaceutical manufacturing environment.
- In-depth understanding and application of validation principles, concepts, practices, and standards.
- Working knowledge of cell therapy manufacturing equipment, utility systems, and supporting infrastructure.
- Experience with digital validation systems, including KNEAT, electronic validation workflows, and data management practices.
- Experience developing and executing temperature mapping studies and autoclave heat penetration studies.
- In-depth knowledge of current Good Manufacturing Practices (GMPs).
- Experience supporting regulatory inspections and interactions with health authorities.
- Excellent verbal, written, and interpersonal communication skills
- Demonstrated investigation and report writing skills.
- Proficient in Microsoft Office applications.
- Strong analytical, problem-solving, and critical-thinking skills.
The salary range for this position is: $123,930.00 - $160,380.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 [redacted] on Twitter at www.twitter.com/kitepharma.
For Current Kite Pharma Employees and Contractors:Please apply via the Internal Career Opportunities portal in Workday.
