Job Vacancy Manufacturing Engineer III Kite Pharma



Job title: Manufacturing Engineer III

Company: Kite Pharma

Job description: Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors:

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Job Description

Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs.

Responsibilities (including but are not limited to):

  • Translate process requirements and MES system best practices into practical, usable electronic batch records
  • Develop design requirements, functional specifications, and support computer system validation strategy
  • Participate in the development of Knowledge base for batch record design, integration with process/test equipment and other electronic business and automation systems
  • Collaborate with vendors (as part of a team) to define user requirements and ensure the system design meets business requirements
  • Develop business processes, guidelines, Work Instructions and SOPs to support the MES systems
  • Partner with internal departments & external vendors to assist in maintaining the validated status of the MES system.
  • Document requirements, process flows, new functionality, and creation of SOP/training materials while maintaining all materials and configured software in a central repositories
  • Participate in the development of MES system life cycle strategy and business/technical processes for change management
  • Training super and end users on functionality and process changes as they relate to MES
  • Available for 24/7 support (scheduled and off hours)
  • T

rouble shooting daily operational system issues to define root cause, working in collaboration with Manufacturing, Quality and CoE to build temporary/permanent solutions

  • Administration and maintenance of site MES Production and offline systems

Basic Qualifications

  • MA/MS degree with 3+ years of experience in Werum PAS-X MES Generic Master Batch Record (GMBR) Design and System Administration, Mfg in a biotech/pharma industry Or
  • Bachelor’s degree with 5+ years of experience in Werum PAS-X MES Generic Master Batch Record (GMBR) Design and System Administration, Mfg in a biotech/pharma industry Or
  • High School degree with 9+ years of experience in Werum PAS-X MES Generic Master Batch Record (GMBR) Design and System Administration, Mfg in a biotech/pharma industry

Preferred Qualifications

  • Working knowledge of cGMP manufacturing and regulatory regulations and requirements for
  • Knowledge of cell culture or cell therapy manufacturing technical support
  • Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing
  • Knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards
  • Knowledge and application of Good Automated Manufacturing Practice (GAMP) framework for risk-based approach to computer system validation
  • Knowledge and application of IT infrastructure and applications (server virtualization, security, wireless communication protocols, firewalls, etc.)

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 .

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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 for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, and Singapore employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the poster.

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 to apply for this job.

Expected salary:

Location: California

Job date: Wed, 20 Jul 2022 04:19:17 GMT

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