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Gilead Sciences, Inc. CQV Engineer in Hoofddorp, Netherlands

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

At Kite, we empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Job Description

As Validation Engineer III, you’ll be joining a team, in which employees of all backgrounds and experiences are respected, where working together focused on saving lives, by finding the cure for cancer, is a daily activity. You’ll be reporting directly to the Validation Manager.

Your responsibilities

  • Responsible for performing validation of equipment, instrument, facilities, and utilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.

  • Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.

  • May also investigate and trouble-shoot problems which occur and determine solutions.

  • Coordinates and executes validation change control.

  • Preparation of protocols, reports and data tables including identification and resolution of non-conformances.

  • Maintains all documentation pertaining to validation.

  • Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.

  • Contributes directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel.

  • As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.

  • Independently applies validation principles to work assignments, reviews and approves documents and resolves problems.

  • Coordinates assigned projects and represents department on project teams.

  • May provide day-to-day guidance and training to validation technicians.

  • Serves as an information resource to validation engineers, contractors and vendors.

Knowledge / Skills

  • Extensive understanding and application of validation principles, concepts, practices, and standards.

  • Proficient in current Good Manufacturing Practices (GMPs).

  • Full working knowledge of equipment and systems.

  • Full knowledge of industry practices.

  • Fluent in English

  • Strong verbal, written, and interpersonal communication skills are required.

  • Investigation and report writing skills.

  • Proficient in Microsoft Office applications.

Education / Experience

  • 6+ years of relevant experience and bachelor’s degree in science or related field.

  • 4+ years of relevant experience and a MS or MBA.

  • 2+ years or relevant experience and a PhD.

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 .

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Change The World With Us

Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.

While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

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