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Oceanside, California, United States
Onsite
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Everyone 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.
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 @KitePharma on Twitter at www.twitter.com/kitepharma.
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Please apply via the Internal Career Opportunities portal in Workday.
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