Process Engineer I

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.

Job Description

Under minimal supervision, the main accountabilities are focused on the front line technical support of manufacturing operations while closely collaborating with the Quality and Product Sciences Unit.

Responsibilities (include but are not limited to):

• Provides frontline MES support for manufacturing of cell therapy products
• Resolves routine manufacturing's escalations
• Replicates issues and identifies corrective actions

• Ensures successful manufacturing production runs by assessing risk, implementing preventative measures, investigating, and troubleshooting MES related events
• In conjunction with various internal and external stakeholders, investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools
  
  • Devises and implements CAPAs to address root cause and ensure effectiveness
  • Initiates deviations and Change controls
• Authors Root Cause Analysis, Change Controls and CAPAs (minor to moderate in complexity)
• Develops design requirements and designs processes in PAS-X (minor to moderate in complexity)
• Good understanding of design, MES system Life Cycle management, interface, troubleshooting and re-creation of minor to moderate in complexity issues
• Implements continuous design changes (minor to moderate complexity) that are required by the Business as a result of Change controls, CAPAs, Enhancements.
• Authors functional specifications, and test scripts (OQ/PQ) for the MES System Validation for minor to complex projects
• Develops Work Instructions and SOPs to support the MES system
• Authors minor to moderate Product impact assessments (IA) with minimal guidance.
• Performs OQ/ PQ, functionality testing
• Supports manufacturing through risk assessments (RA) and remediation measures (e.g. RA SME, technical SME, lead RA)
• Represents MES technical Operations in Site Change Control, CAPA and deviations meeting
• Leads minor to moderate projects in MES
• Supports regulatory inspections and may serve as SME
• Supports that development of training material and executes MES training activities on functionality and process changes and creation of SOPs
• Participates in the development of MES system life cycle strategy management
• Supports Commercial Process and Metrics Monitoring (e.g. data collection, verification)
• Participates in the implementation of different Projects in MES
• Identifies additional training or self-help improvement needs and communicates recommendations
• Requires general supervision from management
• Additional duties as assigned.

Requirements:

• BS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 2+ years of experience OR
• MS in Biochemical Engineering, Chemical Engineering, Biotechnology or equivalent with 0+ years of experience

Preferred:

• Engineering degree preferred
• Cell culture, Cell therapy and/or aseptic processing experience
• Broad technical knowledge of cGMP compliance and experience with leading investigations, writing, deviation reports, change controls, and corrective actions
• Experience with investigation and root cause analysis tools
• Skilled at creating and delivering presentations
• Proficiency in using Microsoft Word, Excel, Presentation, Access, and Project
• Utilizes technical writing strategies to ensure content is clear and concise
• Possesses good communication skills
• Experience leading cross functional teams to obtain project deliverables
• Working knowledge of scientific and engineering principles
• Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus
• Knowledge of ERP systems implementation is desirable

The salary range for this position is: $86,275.00 - $111,650.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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:

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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 Sign up to follow @KitePharma on Twitter at ;br>
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Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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.

Kite Pharma 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:

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