Offers “Roche”

Expires soon Roche

Engineer I/II, Control Systems

  • Oceanside (San Diego)
  • IT development

Job description



·  Job facts

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.
·  Support 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, 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.
·  Adhere to company policies regarding performance management, department time reporting and notification requirements, budget, and expense reporting guidelines.
·  Support equipment/software FAT, field testing and commissioning.
·  Interact with vendors to ensure systems meet site requirements.
·  Support projects for technical content, track project deliverables, and provide status updates to project team.
·  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.

Education and Experience

·  Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Electrical, or Computer Science preferred) 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 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 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 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.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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