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Gilead

Principal Engineer, Global Validation

For Current Kite Pharma Employees and Contractors:

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

Job Description

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 motivated individual to join us as a Principal Engineer, Global Validation. This Director level position will be located at the Kite headquarters and perform as leader in Kite’s Quality Engineering department. Reporting to Kite’s Head of Quality Engineering, you’ll interface and build strong partnerships with Product Development, clinical – and commercial Quality groups, Engineering, Manufacturing and other parts of Kite’s organization as well as external service providers.

This is a global role and the successful applicant will need to have global mobility to visit project sites to establish the CQV program, form the team responsible and perform periodic checks on progress and compliance to critical program elements. In this role, you will define and manage Kite’s Commissioning, Qualification and Validation (CQV) program and assume global ownership of the CQV process. In support of Kite’s globalization, the focus is on consistent application of best industry practices defined as global policy and procedures. As manufacturing processes and requirements are to be globally consistent, you will ensure compliance with these procedures and any applicable regulatory guidelines.

Responsibilities (include, but are not limited to):

  • Assume ownership of the policies and procedures defining Kite’s CQV program
  • Provide guidance and support to partners in Validation like Product Development (PD), Supply Chain (SC) and Facilities & Engineering (F&E) teams in support of cell therapy operations
  • Support Commissioning and Qualification of R&D, Clinical and Commercial sites supporting Kite’s globalization in compliance with internal procedures and policies as well as regulatory requirements
  • Function as global Subject Matter Expert for Validation and provide guidance to internal and external stakeholders
  • Champion integration of Computer Systems Validation (CSV) activities, in collaboration with CSV, Automation and IT partners, into CQV
  • Manage relationships and resourcing with external suppliers of CQV services
  • Develop and maintain CQV training and templates
  • Support facility upgrades and – changes with technical expertise in design and delivery
  • Partner with peers in the QE department around validation strategies
  • Support regulatory inspections and audits
  • Review technical/investigation reports as appropriate
  • Review and approve proposed changes to systems and procedures, as appropriate
  • Perform other duties as required

Skills/Qualifications:

  • Bachelor’s degree in an engineering or scientific discipline with 12+ years of relevant experience
  • 8 years of CQV experience in a GMP environment (Drug Substance or Drug Product)
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10)
  • 7 years of management experience
  • Quality Assurance, cGMP, Health Authority Regulations and Validation practices/principles
  • Strong knowledge of cGMP, CQV, Industry Best Practice Guides and quality systems
  • Experience with internal and external audit principals
  • Proficient in MS Word, Excel, Power Point and other applications
  • Strong written and verbal communication skills
  • Ability to communicate and work independently with scientific/technical personnel
  • Excellent analytical skills
  • Experience in the medical and/or pharmaceutical industry, preferred
  • ASQ, Black Belt/Green Belt certifications, preferred

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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.
 

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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.

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For Current Kite Pharma Employees and Contractors:

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

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