88-50100317 Industrial Engineer, Automation
About The Position
The Position Genentech, Inc. seeks an Industrial Engineer, Automation at its Oceanside, CA location. Duties: Perform engineering design services for existing pharmaceutical manufacturing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement. Produce and review design drawings and specification documents. Generate, execute, and review design testing, evaluate and participate in functional specification testing, and perform field inspection services. Generate, execute, and evaluate Installation, Operational, and Performance Qualification protocols, and approve Good Manufacturing Practice Lifecycle Documents (e.g. risk documents, trace matrices, periodic review, etc.). Initiate, execute, and track progress of change records. Perform design and qualification activities following Genentech/Roche business processes to deliver quality, on-time results that are reconciled to the budget and cost analysis. Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met. Troubleshoot process automation and critical process utility systems. Support plant operations to assess discrepant events and changes for systems 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 Standard Operating Procedures and Work Instructions for daily and project deliverables and provide 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. Conduct equipment/software Factory Acceptance Testing, field testing and commissioning. Interact with vendors to 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. Provide input into Master Plans and Project Plans with automation scope. 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. Telecommuting permitted up to 2 days per week.
Requirements
- Master’s degree in Industrial Engineering or a related field and 3 years of experience in the position offered or a closely related position
- 3 years of experience with the following: Using automation systems or instrument and control systems, including Emerson DeltaV Process Control System (PCS) to trouble-shoot, perform interventions in software, and make modifications to software for improvements
- Design and construction of process, utility, and manufacturing control systems
- Performing qualification of control and computer systems to ensure requirements and standards have been met and that system operates as intended
- Generating and reviewing engineering drawings and design/functional specifications
- Developing, implementing, and testing design solutions to improve operations using Good Automated Manufacturing Practices and Good Manufacturing Practice
Responsibilities
- Perform engineering design services for existing pharmaceutical manufacturing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement.
- Produce and review design drawings and specification documents.
- Generate, execute, and review design testing, evaluate and participate in functional specification testing, and perform field inspection services.
- Generate, execute, and evaluate Installation, Operational, and Performance Qualification protocols, and approve Good Manufacturing Practice Lifecycle Documents (e.g. risk documents, trace matrices, periodic review, etc.).
- Initiate, execute, and track progress of change records.
- Perform design and qualification activities following Genentech/Roche business processes to deliver quality, on-time results that are reconciled to the budget and cost analysis.
- Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.
- Troubleshoot process automation and critical process utility systems.
- Support plant operations to assess discrepant events and changes for systems 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 Standard Operating Procedures and Work Instructions for daily and project deliverables and provide 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.
- Conduct equipment/software Factory Acceptance Testing, field testing and commissioning.
- Interact with vendors to 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.
- Provide input into Master Plans and Project Plans with automation scope.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
