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Senior Manager, Automation Engineering

United States - California - El SegundoManufacturing Operations & Supply ChainRegular

Job Description

Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, or white blood cells, to express either chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies.

The Senior Manager, Automation Engineering will be part of a team that will serve as System Owner and change agent for multiple systems for Kite’s Cell therapy Manufacturing Facility at El Segundo, CA. The successful candidate will have demonstrated proficiency in leading automation/technology projects, project management, system administration and manufacturing operations support.

Responsibilities (including but are not limited to):

  • Management of automation/technology projects scope definition and control, schedule development and management, project reporting, and change control /management
  • Apply best practices to help translate process and user requirements into practical, maintainable automation designs
  • Develop design requirements, functional specifications, and support computer system validation strategy
  • Collaborate, develop, and/or own change control, deviation and CAPA investigation and development utilizing company QMS with cross-functional team
  • Participate in the development of global standards for design, configuration, and integration with process/test equipment, other electronic business systems 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 manufacturing systems
  • Partner with internal departments & external vendors to assist in commissioning manufacturing system
  • Document requirements, process flows, new functionality, and creation of SOP/training materials while maintaining all materials and configured software in central repositories
  • Participate in the development of 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 manufacturing systems
  • Travel as required to participate in technical meetings (Approximately 10%)
  • Available for 24/7 support (scheduled and off hours)
  • Troubleshooting daily manufacturing system issues to determine root cause, working in collaboration with Manufacturing, Quality and Global technical team to build temporary/permanent solutions
  • Administration and maintenance of site manufacturing Production and offline systems

Basic Qualifications:

  • Master’s degree with 6+ years of experience in engineering, manufacturing in biotech/pharma industry Or
  • Bachelor’s degree with 8+ years of experience in engineering, manufacturing in biotech/pharma industry Or
  • High School degree with 12+ years of experience in engineering manufacturing in biotech/pharma industry

Preferred Qualifications:

  • Bachelors’ Degree in Engineering, Computer Science, or equivalent industry experience
  • Lean Six Sigma Green Belt or higher (preferred)
  • Project Management Professional (PMP) (preferred)
  • 10+ years of experience in Pharmaceutical, Biotech or Cell Therapy industries
  • 5+ years of experience with current Good Manufacturing Practice (cGMP) Regulations
  • 2+ years of experience with Process Control System (PCS) Design and System Administration (Preferred)
  • 2+ years of experience with Werum PAS-X MES Generic Master Batch Record (GMBR) Design and System Administration (Preferred)
  • Demonstrates knowledge of new product introduction and tech transfer
  • Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals
  • Knowledge of upstream and downstream drug manufacturing processes and/or cell therapy manufacturing processes
  • 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.)