Full Job Description
We are currently seeking an Industrial Automation Engineer to support mechatronics and automation-related Commissioning and Qualification projects at a VTI client in Thousand Oaks, CA. The role will require effective collaboration and support with functional areas such as Manufacturing, Quality, Process Engineering, Validation, and other applicable stakeholders.
Responsibilities:
• Lead the start-up and commissioning of automated equipment, systems, and critical process utility systems.
• Lead automation issue identification and resolution, including all compliance aspects such as Deviation investigation, Change Control, and Corrective and Preventive Action (CAPA)
• Produce and review design drawings and specification documents (URS, FS, DS, etc.)
• Generate, execute, and review Installation, Operational, and Performance Qualification protocols.
• Generate, review, and approve GMP Lifecycle Documents (e.g., risk documents, trace matrices, periodic reviews). Initiate, execute, and track progress on change records.
• Review and approve vendor information packages, including drawings and specifications, to ensure validation and control system requirements are met.
Qualifications:
• Bachelor's degree in engineering (Mechatronics, Mechanical, Electrical, or Computer Science preferred) with 7 years' experience, or a Master's degree in Engineering (Mechatronics, Mechanical, Electrical, or Computer Science preferred)with 5 years' experience.
• Minimum of 7+ years of applicable industrial automation systems integration and/or programming control experience.
• Minimum of 5+ years in the pharmaceutical/biotech industry/GMP experience.
• Knowledge of process, utility, and building control systems.
• Strong understanding of GMPs, Computerized Systems Validation/Assurance (CSV/CSA) and Good Engineering Practice (GEP), including ISA S88/S95, GAMP, ASTM E2500, ISPE guidance, 21 CFR Part 11, Annex 11, Data Integrity.
• Commissioning, Start-Up, and Qualification experience related to control and computer systems.
• Experience in the implementation of PLC, HMI and SCADA automation systems such as Rockwell, Factory TalkView, Siemens, Honeywell, Delta V, etc.
• Ability to work most of the time independently with minimal direct supervision.
• Demonstrate excellent interpersonal skills.