Senior Engineer, Control Systems

United States of America, California, Oceanside

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Essential

  • 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 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.
  • Generate, review, and maintain Master Plans and Project Plans with automation scope.
  • 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).
  • All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
  • 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.
  • Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.