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Engineer, Validation

Expired Job

Kite Pharma, Inc. Santa Monica , CA 90405

Posted 5 months ago

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job

Job Description

We are seeking a highly motivated individual to join us as a Validation Engineer. 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 reporting to the Associate Director, Facilities and Maintenace.

Responsibilities (include but are not limited to):

  • Creation and execution of qualification protocols (IOQ / PQ), including identification and resolution of non-conformances/deviations.

  • Provide equipment, system and facility qualification guidance and strategy during project planning and development phases.

  • Oversee and manage validation instrument inventory including calibrations.

  • Review technical documentation including protocols & summary reports for IOQ / PQ testing, and validation SOPs.

  • Perform temperature mapping and other miscellaneous validation activities.

  • Manage contractors performing equipment and system qualifications.

  • 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 technical specifications.

  • 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 5+ years of validation experience in the biotechnology, pharmaceutical or medical device industry. Engineering degree is preferred.

  • Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biotechnology, pharmaceuticals and medical devices.

  • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is essential; utility and facility validation experience is strongly preferred; process validation experience is a plus

  • Cell culture experience 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

  • 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, and demonstrated troubleshooting and problem solving skills.

  • Ability to function efficiently and independently in a changing 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 this collaborative work environment.

  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

#LI-JK1

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 jobs in France:

Conformment la Loi " Informatique et Liberts " (06/01/78), nous vous informons du fait que les donnes personnelles renseignes pourront faire l'objet d'un traitement informatique par Gilead et pourront tre transmises aux Organismes Sociaux. Par ailleurs, vous disposez d'un droit d'accs, de rectification et de suppression des donnes vous concernant. Vous pouvez exercer ce droit en contactant: FranceDataPrivacy@gilead.com

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


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Responsibilities (include but are not limited to): * Creation and execution of qualification protocols (IOQ / PQ), including identification and resolution of non-conformances/deviations. * Provide equipment, system and facility qualification guidance and strategy during project planning and development phases. * Oversee and manage validation instrument inventory including calibrations. * Review technical documentation including protocols & summary reports for IOQ / PQ testing, and validation SOPs. * Perform temperature mapping and other miscellaneous validation activities. * Manage contractors performing equipment and system qualifications. * 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 technical specifications. * 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 4+ years of validation experience in the biotechnology, pharmaceutical or medical device industry. Engineering degree is preferred. * Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biotechnology, pharmaceuticals and medical devices. * Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) is essential; utility and facility validation experience is strongly preferred; process validation experience is a plus * Read and interpret drawings such as PFDs, P&IDs and electrical schematics. * 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, and demonstrated troubleshooting and problem solving skills. * Ability to function efficiently and independently in a changing 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 this collaborative work environment. * Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities   #LI-HH1 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. Kite Pharma, Inc. Santa Monica CA

Engineer, Validation

Expired Job

Kite Pharma, Inc.