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Process Automation Engineer II/Senior

Company: Roche
Location: Oceanside
Posted on: September 19, 2022

Job Description:

The Position

The Automation Engineers are an integral part of the Oceanside Automation team within Genentech's Manufacturing Science and Technology team and serve the site's broader needs in our digitization efforts. The Oceanside manufacturing site is a large-molecule drug substance facility designated as a Pivotal/Launch site to help advance Genentech/Roche pipeline products at the Phase III and Commercial launch stages. We are looking for individuals who are comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical behaviors, and have an agile/network mindset. The ability to collaborate is crucial, and success in the role will require the individual to thrive in a team environment and not act solely as an individual contributor.

In this role, you will be responsible for providing automation and instrumentation and control engineering capabilities and expertise to the various functions including generating qualification protocols and maintaining the validated state of systems and processes. You will focus on providing long-term support for existing and future facilities with respect to the automation and instrumentation and control systems for process, utility and building systems and provide technical input to automation impacting projects with small and/or focused scope.

Essential Job Functions

  • Perform automation and instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement.
  • Produce and review design drawings and specification documents (URS, FS, DS, etc.).
  • Generate, execute, and review Installation, Operational, and Performance Qualification protocols.
  • Generate, review, and approve GMP Lifecycle Documents (e.g. risk documents, trace matrices, periodic review, etc.)
  • Initiate, execute, and track progress of change records.
  • Support the start-up and troubleshooting of automation and critical process utility systems.
  • Support the plant that operates 24x7 to assess discrepant events and changes for automation impact, deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, and participate in site coordination meetings.
  • Adhere to site SOPs and WIs for daily and project deliverables and provide improvements to business processes.
  • Support inspection activities to present automation design and qualification deliverables.
  • Attendance and participation in department and staff meetings.
  • Maintain training qualifications.
  • Support equipment/software FAT, field testing and commissioning.
  • Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Fosters a positive safety culture in which no one gets hurt.
  • Authoring new batches recipes within the MES (Syncade)
  • Analyze existing workflows or manufacturing procedures and suggest improvements
  • Handling manufacturing support calls related to the MES recipes

    Education and Experience
    • Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) or related scientific discipline and 4 years experience, or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 2 years experience.
    • Minimum of 4 years applicable automation and/or instrument and control system experience.
    • Minimum of 1 year in the pharmaceutical/biotech industry/GMP experience.

      Knowledge, Skills and Abilities
      • Experience with Biopharmaceutical manufacturing, design or/and construction.
      • Knowledge of process, utility and building control systems.
      • Knowledge of GMP guidelines, experience in generation of controlled documents.
      • Qualification experience related to control and computer systems.
      • Ability to generate engineering drawings and specifications.
      • Knowledge of ISA standards, PID control theories and techniques.
      • Knowledge of PLC (programmable logic controllers), and associated programming languages (RSLogix Preferred).
      • Practical knowledge of DeltaV programming, and associated programming languages
      • Demonstrate good interpersonal skills with an ability to interact well with a variety of personalities, discipline skills and educational levels.
      • Demonstrate good written and verbal communication skills.
      • Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.
      • Ability to work most of the time independently with direct supervision.

        Work Environment/Physical Demands/Safety Considerations
        • Work in a standard office environment.
        • May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots. No make-up or jewelry can be worn when working in the clean room environment.
        • May work with hazardous materials and chemicals.

          Candidates may be hired at a Engineer II or Senior Engineer level depending on experience.

          Genentech offers full relocation support, along with a comprehensive total rewards package for this role.

          Who we are

          A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

          Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.

          Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.

          Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.

Keywords: Roche, Oceanside , Process Automation Engineer II/Senior, Engineering , Oceanside, California

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