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Automation Engineer III
Ref No.: 20-02554
Location: Vacaville, California
Considered the founder of the industry, our client has been delivering on the promise of biotechnology for over 40 years. Our client is considered the leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.

Summary: Maintain, update, upgrade and operate the Programmable Logic Controller (PLC) and Vendor Supplied Controller (VSC) systems in a qualified state.

Job Responsibilities:
Provide automation design and support to the systems controlled via PLCs (Programmable Logic Controllers), VSCs (Vendor Supplied Controllers), and Integrity Testers (ITs). This work will include working with all applicable departments, including Manufacturing, Quality, and Technology, to implement continuous improvement changes, support MAR (Make Assess Release) activities, and assist on capital projects when required. Activities include:
o Develop, review and approve applicable automation-related specifications and any other related documentation.
o Perform off-line and on-line coding, testing, and peer reviewing.
o Support or lead design, development and execution of Automation Change Records (ACRs) and control qualification/commissioning test documentation.
o Provide technical assessments of proposed changes from other departments and evaluations of discrepancies that occur during manufacturing operations.
o Perform troubleshooting of process, equipment, and system malfunctions or failures involving PLCs / VSCs / ITs, including after-hours support.
o Perform detailed reviews of executed ACRs and tests for completeness and accuracy.
o Lead the implementation of immediate corrective and preventative actions to ensure continued compliant operation.
o Serve as the automation representative across functional departments at various levels to drive efficient issue resolution and change implementation.
Train junior engineers on configuration standards and engineering best practices for all applicable PLC, VSC and IT4 platforms.
Function as System Owner Delegate as designated in 200-G05-090 – “Vacaville GMP Computerized Systems QR020 Compliance.
Work performed mostly in office environment and in CCP1 & CCP2 Manufacturing areas.

Experience (may vary depending on site size/scope): Working experience with software development methodologies and automated systems life cycle support in a regulated industry.
Through knowledge of Good Manufacturing Practices (cGMPs), S88 and GAMP, particularly as they relate to the operation, validation, and maintenance of computer-controlled systems.
Solid understanding of basic engineering techniques and principles and the ability to apply that knowledge as required.
Education: BS or MS Degree in Chemical, Electrical Engineering or equivalent training and a minimum of 5 years of related experience.