Validation Engineer II

Kite Pharma • El Segundo, CA

9d

About The Position

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.

Requirements

• Bachelor’s degree in a science or related discipline with at least 4 years of relevant validation or GMP‑regulated industry experience, OR Master’s degree or MBA with at least 2 years of relevant experience.

Nice To Haves

• Strong understanding and application of validation principles, concepts, practices, and industry standards .
• Working knowledge of current Good Manufacturing Practices (cGMPs) .
• Working knowledge of equipment, utility systems, and manufacturing processes .
• Familiarity with industry best practices related to validation and qualification.
• Proven investigation and problem‑solving skills .
• Strong verbal, written, and interpersonal communication skills .
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Experience working independently while effectively collaborating within cross‑functional teams.

Responsibilities

• Perform validation activities for equipment, utility systems, facilities, processes, and automation systems in compliance with approved SOPs , cGMPs , and applicable regulatory requirements.
• Execute validation test plans according to approved protocols; collect samples, tabulate results, and organize complete data packages.
• Compile, analyze, and interpret validation data; prepare validation reports and provide recommendations for improvements or corrective actions.
• Investigate and troubleshoot validation‑related issues; determine and document appropriate solutions.
• Coordinate and execute validation change controls , including preparation of draft protocols, reports, data tables, and supporting documentation.
• Maintain complete, accurate, and inspection‑ready validation documentation .
• Assist in the development and revision of validation procedures and protocols , as needed.
• Coordinate and oversee contract validation personnel through completion of assigned activities.
• Participate on cross‑functional project teams to support site and project objectives.
• Provide day‑to‑day guidance and training to validation technicians, as appropriate.
• Serve as a technical resource to validation staff, contractors, and vendors.
• Resolve validation issues of moderate scope with limited direct supervision.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees