Senior Automation Engineer

Company: Genentech
Location: Oceanside
Posted on: March 17, 2023

Job Description:

The PositionSummaryThe Sr. Automation Engineer is an integral part of the Oceanside site and closely connected to the Roche/Genentech Global network. The Oceanside site is a large molecule drug substance facility delivering multiple commercially licensed life saving medicines as well as a pivotal/launch site, responsible for delivering Genentech/Roche pipeline products at clinical and commercial launch phases.There are many exciting advancements happening at the Oceanside campus, including constructing a new small-batch biologics facility at the forefront of next-generation, innovative manufacturing and environmentally sustainable productionWe are looking for an individual who is ready to learn, collaborate, and create solutions that will serve the expanding needs of the existing operations as well as the new biologics facility. 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.This role is responsible for providing automation, instrumentation and control, and system level engineering capabilities and expertise to the Engineering Group including generating qualification protocols and maintaining the validated state of systems and processes. Focus on providing long-term support for existing facilities with respect to the automation and instrumentation and control systems for process, utility and building systems. Lead automation impacting projects with small and/or focused scope and provide input into strategic initiatives.Job ResponsibilitiesEssential

• Perform automation, 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 design testing, generate and participate in functional specification testing, and perform field inspection services.
    • Generate, execute, and review Installation, Operational, 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.
    • Manage personal project activities (design and qualification) following Genentech/Roche business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget.
    • Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.
    • Lead the start-up and troubleshooting of automation and critical process utility systems.
    • Support plant operations 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, participate in site coordination meetings and attend network meetings.
    • Adhere to site SOPs and WIs for daily and project deliverables and drive improvements to business processes.
    • Support inspection activities to present automation design and qualification deliverables and strategy (e.g. Qualification Project Plans and Master Plans).
    • Attendance and participation in department and staff meetings.
    • Maintain training qualifications.
    • Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines.
    • Automation lead for equipment/software FAT, field testing and commissioning
    • Interact with vendors ensure systems meet site requirements
    • Provide scope, qualification, resource, and budget estimates for automation impacting projects.
    • Manage contractor staff, track project deliverables, and provide status updates to project team.
    • Select external contractors with appropriate skill sets.
    • Manage teams (contractor and FTE staff) by setting clear expectations for work delivered and behaviors. Monitor performance and ensure contractual obligations are met. Complete timely review of time sheets and invoices.
    • Provide input into network/global business processes and procedures (e.g. GSPs).
    • Fosters a positive safety culture in which no one gets hurt.Job RequirementsEducation and Experience
      • Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 8 years experience, or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 7 years experience.
      • Minimum of 8 years applicable automation and/or instrument and control system experience.
      • 5 years 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, P&IDs and practices for instrumentation.
        • Knowledge of PID control theories and techniques.
        • Proficient knowledge of Rockwell and SCADA,Emerson's DeltaV, managing interfaces to external systems including OPC Servers, interfaces to SAP and associated programming languages
          • Demonstrate good organizational and time utilization skills.
          • 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.
            • Demonstrate strong working knowledge of PC based programs and web based systems.
            • Ability to work independently with no 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.Relocation benefits are available for this position#ptcareersGenentech 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.Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Keywords: Genentech, Oceanside , Senior Automation Engineer, Engineering , Oceanside, California