Process Automation Engineer I/II

Oceanside
California, United States of America


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The Position

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. Provide input into strategic initiatives. 

Job Responsibilities

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, 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.
  • 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.
  • This position may support Systems Automation projects, systems lifecycle asset replacement, system owner responsibilities involving automation change control, system maintenance, upgrades, and backup, disaster recovery.
  • 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 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 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.
  • 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.

Job Requirements

Education and Experience

  • Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical,  Electrical, or Computer Science preferred) and 5 years experience, or Master’s degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) and 4 years experience.
  • Minimum of 5 years applicable automation and/or instrument and control system experience.
  • Minimum of 3 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 and practices for instrumentation.
  • Knowledge of PID control theories and techniques.
  • Knowledge of programmable logic controllers, and associated programming languages (RS Logix Preferred).
  • Practical knowledge of distributed control systems, and associated programming languages – (DeltaV and Seimens Insight Apogee Preferred).
  • Knowledge in computer programing and database languages such as OSISoft PI, Process book, PI Event Frames (EF), Asset Framework (AF), SQL, .NET, Visual basic, Business Objects, AgileDoc etc.
  • Experience in Virtualization (Hyper-V),DeltaV Virtual Studio, configure servers, hardware, software, networking, security and storage etc.
  • Experience with Emerson DeltaV Process control system (PCS) system infrastructure (preferred).
  • Familiar with configuring and maintaining Emerson Syncade Manufacturing Execution Systems (MES) or other MES (preferred).
  • Proficient knowledge of PLC/DCS, SCADA, managing interfaces to external systems including OPC Servers, interfaces to SAP and associated programming languages.
  • Familiar with Product Lifecycle Management (PLM), Trackwise, SAP, Electronic Document Management System (EDMS).
  • Knowledge of computer aided manufacturing automation.
  • 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 most of the time independently with minimal direct supervision.

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.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.

At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.


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