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Sr. Automation Engineer

3 months ago

Oceanside, California, United States Gilead Sciences, Inc. Full time

For Current Kite Pharma Employees and Contractors:

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

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

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 Automation Engineer will be part of a team that will serve as System Owner of the Process Control System (PCS) for Kite's Viral Vector Manufacturing Facility in Oceanside, CA. The successful candidate will have demonstrated proficiency in leading PCS deployment and system administration, implementing complex electronic recipes and configuration and integration of the PCS with related business and automation systems.

Responsibilities (including but are not limited to):

  • Translate process requirements and PCS system best practices into practical, usable recipes and executable configurations
  • Develop design requirements, functional specifications, and support computer system validation strategy
  • Participate in the development of global standards for configuration 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 PCS systems
  • Provide leadership to a cross-site, multi-functional (Global Operational Technology, IT, Quality, Supply Chain, Manufacturing, Process Development, etc.) collaboration to implement PCS
  • Partner with internal departments & external vendors to assist in commissioning PCS 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 PCS 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 PCS
  • Travel as required to participate in technical meetings (Approximately 10%)
  • Available for 24/7 support (scheduled and off hours)
  • Trouble shooting daily operational system issues to define root cause, working in collaboration with Manufacturing, Quality and Global to build temporary/permanent solutions
  • Administration and maintenance of site PCS Production and offline systems

Basic Qualifications:

  • Masters' Degree in Engineering, Computer Science, or equivalent with 4+ years of industry experience OR
  • Bachelors' Degree in Engineering, Computer Science, or equivalent with 6+ years of industry experience OR
  • High School Diploma with 11+ years of related experience in the Biotech or Pharma industry

Preferred Qualifications:

  • 5+ years of experience with current Good Manufacturing Practice (cGMP) Regulations preferred
  • 5+ years of experience with industry recognized Process Control System (PCS) such as Emerson DeltaV preferred
  • 2+ years of experience with Werum PAS-X MES Generic Master Batch Record (GMBR) Design and System Administration preferred
  • 2+ years of experience with Rockwell Allen Bradley FactoryTalk Software Suite and Programmable Logic Controllers (PLC) 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 biologics 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.)
  • Lean Six Sigma Green Belt or higher preferred.
  • Project Management Professional (PMP) preferred

The salary range for this position is: $130, $168, 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:

  • 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 .

For jobs in the United States:

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.

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

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT )

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION )

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 Internal Career Site $) 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.