Logo of Huzzle

Sr. Automation Engineer - Biopharmaceutical Process Control & Instrumentation

Applications are closed

  • Job
    Full-time
    Mid, Senior & Expert Level
  • Oceanside

Requirements

  • 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

Responsibilities

  • 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
  • Train super and end users on functionality and process changes as they relate to PCS
  • Travel as required to participate in technical meetings (Approximately 10%)
  • Be available for 24/7 support (scheduled and off hours)
  • Troubleshoot daily operational system issues to define root cause, working in collaboration with Manufacturing, Quality and Global to build temporary/permanent solutions
  • Administer and maintain site PCS Production and offline systems

FAQs

What is the primary focus of Kite, a Gilead Company?

Kite focuses on the development and commercialization of novel cancer immunotherapy products that harness the power of a patient’s immune system to target and kill cancer cells.

Where is the Senior Automation Engineer position located?

The Senior Automation Engineer position is located at Kite’s Viral Vector Manufacturing Facility in Oceanside, CA.

What are the basic qualifications required for this position?

The basic qualifications include a Masters’ Degree in Engineering or Computer Science with 4+ years of experience, a Bachelors’ Degree with 6+ years of experience, or a High School Diploma with 11+ years of related experience in the Biotech or Pharma industry.

What specific experience is preferred for this role?

Preferred qualifications include experience with current Good Manufacturing Practice (cGMP) Regulations, Process Control Systems such as Emerson DeltaV, and System Administration with Werum PAS-X, among others.

Is travel required for this position?

Yes, travel is required for this position, approximately 10% of the time, to participate in technical meetings.

What is the salary range for the Senior Automation Engineer position?

The salary range for this position is $130,220.00 - $168,520.00, depending on experience, qualifications, and geographic location.

Does the role include being available for 24/7 support?

Yes, the role requires the candidate to be available for 24/7 support, including scheduled and off-hours.

What type of environment does Gilead promote?

Gilead promotes a diverse and inclusive workforce, emphasizing a work environment free of harassment and recognizing the individual differences of all employees.

Are there opportunities for professional development within the company?

Yes, Gilead believes in developing its employees and providing an environment where they feel included and empowered to fulfill their aspirations.

What benefits are offered alongside the salary?

Benefits include company-sponsored medical, dental, vision, and life insurance plans, as well as potential eligibility for annual bonuses and stock-based long-term incentives.

At Kite, a Gilead Company, our singular focus is cell therapy to treat and potentially cure cancer.

Science & Healthcare
Industry
1001-5000
Employees
2009
Founded Year

Mission & Purpose

Kite Pharma is a biopharmaceutical company specialising in the development and commercialisation of innovative cancer immunotherapies. Focused on creating groundbreaking treatments, Kite Pharma harnesses the power of living cells to engineer personalised therapies that combat various forms of cancer. Their ultimate goal is to revolutionise cancer treatment by providing effective and targeted therapies tailored to individual patients. With a commitment to advancing scientific discoveries and improving patient outcomes, Kite Pharma's purpose lies in pushing the boundaries of what's possible in the field of oncology through cutting-edge research and the development of transformative cell therapies.