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 this mission! We are seeking a highly motivated individual to join us as a Validation Engineer to support our new commercial manufacturing biotechnology facility in Frederick, MD. You will work with the Engineering and Manufacturing teams in supporting our efforts in this exciting new area of cancer immunotherapy. This role will be a hands-on resource working with the Associate Director of Validation within the Facilities and Engineering organization. Responsibilities (include but are not limited to): Create and execute commissioning, qualification protocols, and validation protocols (CP/IQ/OQ/PQ/PPQ), including identification and resolution of exceptional conditions; Provide equipment, system and facility commissioning and qualification guidance and strategy execution during project planning and development phases; Oversee and manage validation instrument inventory including calibrations and/or certifications; Review technical documentation including protocols & summary reports for CQV lifecycle documentation, other testing, and validation SOPs; Perform temperature mapping and other miscellaneous validation activities; Manage contractors performing equipment and system commissioning, qualifications, and validation; Support process and method transfer validation activities, as necessary by manufacturing and Quality Control labs; Report status and progress of qualification activities or projects to the Leadership team; Perform investigations and implement corrective actions related to CAPAs and deviations; Develop or Review technical specifications documents necessary for generation and/or execution of CQV lifecycle documentation; Support the execution of engineering projects; Other duties as assigned. Requirements: BS or MS degree in Biochemical Engineering, Chemical Engineering, Mechanical Engineering, Biotechnology or Life Sciences with 8+ years of validation experience in the biotechnology, pharmaceutical, medical device industry or related analytical/micro lab operations. Engineering degree is preferred; Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biotechnology, pharmaceuticals and medical devices; Equipment commissioning and qualification experience in a cGMP environment (IQ, OQ, PQ) is essential; utility and facility validation experience is strongly preferred; Process and/or laboratory methods validation experience is strongly preferred; Cell culture experience is a plus; Analytical and Microbiological laboratory equipment qualification and related method validation is preferred; Read and interpret drawings such as PFDs, P&IDs and electrical schematics; Working knowledge of scientific and engineering principles related to the bio; Working knowledge in computerized system validation is a plus; Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products, and process development; Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team-based decisions; Ability to think critically with demonstrated troubleshooting and problem-solving skills; Ability to function efficiently and independently in a dynamic, fast paced environment; Self-motivated and willing to accept temporary responsibilities outside of initial job description; Well-developed computer skills and fluent with Microsoft office applications; Excellent interpersonal, verbal and written communication skills are essential in our collaborative work environment; Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities and business needs. Does this sound like you? If so, please apply today! #LI-ML1 IND123 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 . For jobs in the United States: As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 careers@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job.