SR. AUTOMATION & VALIDATION ENGINEER

$125,000 - $150,000/Yr

Jsat Automation - Oakland, CA

Full-time - Mid Level

Oakland, CA

Professional, Scientific, and Technical Services

About the position

JSat Automation is seeking a Senior Automation and Validation Engineer to join their Emeryville office. This role focuses on designing and developing manufacturing control systems to support process operations, while also fostering long-term relationships with clients as a technical partner. The engineer will be responsible for managing projects, developing validation documents, and ensuring compliance with FDA regulations, all while working closely with a diverse team of professionals.

Responsibilities

• Lead the designing and development of manufacturing control systems in support of process operations.
• Interact with client personnel to identify and analyze continuous improvement through automation upgrades.
• Manage or support projects as the primary controls resource.
• Develop validation documents per FDA cGMP and GAMP standards, functional specifications, design specifications and requirements trace matrices.
• Design, program, test and validate process control automation systems.
• Prepare and execute validation protocols (AIQ, IQ, OQ) for 21 CFR Part 11 compliance per FDA requirements.
• Manage, document, and implement these upgrades through changes control procedures.
• Manage the activities of on-site project resources; define detailed plan necessary to complete approved projects on schedule and within budget.
• Design, develop, and implement technical solutions by establishing integration strategies, configuring, and programming PLCs, DCSs as well as design, build, install and integrate automation control system hardware, panels, and field devices.
• Manage capital projects including but not limited to: Control system software development, Control system hardware design, Network design, MES system implementation, Recipe management, User requirement specification development, Process equipment installations.
• SOP development and training on Automation Systems.
• Troubleshoot, analyze, and resolve field control system issues.
• Develop, review, and / or execute automation qualification and validation protocols.
• Other duties as assigned.

Requirements

• Minimum BS Degree in Engineering (Computer Science, Electronics, Electrical, Chemical, etc.) or equivalent with over 5 years experience in process industry.
• Strong familiarity with ISA-88 and ISA-95 standards.
• Extensive experience with Ignition SCADA platform and MQTT Sparkplug technology.
• Experience with Ignition from Inductive Automation Core Modules (including Perspective, Alarming, SQL Bridge, Reporting).
• Experience with Allen-Bradley PLC (including ControlLogix, CompactLogix, Micro800 series PLCs).
• Experience in managing VMware ESXi, Linux, and Windows virtual machines.
• Proficiency in Docker containers, with the ability to deploy and manage containerized applications.

Nice-to-haves

• Python, C#, NODE-RED Programming.
• Preferably Gold Certified Ignition Engineer or in the process of obtaining certification.
• Previous experience in the life sciences industry is a plus.
• Project Management skills and experience are plus.
• Process knowledge is plus.

Benefits

• Health benefits
• Vacation
• Competitive salary based on experience