Automation and Controls Engineer

Responsibilities

• Maintain Allen-Bradley PLC systems (ControlLogix, CompactLogix) using RSLogix 5000 / Studio 5000; develop and document ladder logic, function block, and structured text programs to meet bioprocessing control requirements.
• Configure, troubleshoot, and maintain DeviceNet and other industrial fieldbus networks (Ethernet/IP, ControlNet) across the PBF facility; manage device profiles, network topology documentation, and connection maintenance.
• Support SCADA and HMI system development, deployment, and ongoing maintenance for bioprocessing equipment including bioreactors, fermenters, chromatography systems, and utility skids.
• Execute Computer System Validation (CSV) activities per 21 CFR Part 11 and EU Annex 11, including authoring and executing IQ/OQ/PQ protocols, managing change control records, and maintaining audit trail documentation.
• Maintain plant OT network infrastructure; collaborate with IT/OT convergence teams on network segmentation strategy, industrial cybersecurity controls, and equipment lifecycle management.
• Manage industrial device configuration profiles and asset documentation; maintain accurate as-built drawings, wiring diagrams, and instrument loop documentation.
• Partner with process engineers and manufacturing staff to automate unit operations and integrate new equipment into the facility control architecture; lead automation scope definition for capital projects.
• Support regulatory inspections (FDA, DISA) by maintaining up-to-date system documentation, validation records, and audit trails; perform root cause analysis and document corrective and preventive actions (CAPAs) for automation-related deviations.
• Perform light duties and other related duties as required and assigned, including working in other sections.

Qualifications

• A BA/BS degree in engineering, computer science, and/or biotechnology fields, or a closely related technical discipline and a minimum of 6 years of GMP automation experience in a GMP-regulated pharmaceutical, biopharmaceutical, or government research manufacturing facility.
• Understanding of GMP manufacturing practices and regulated computerized systems.
• Experience with GMP documentation practices, change control procedures, deviation management, and regulatory inspection support (FDA, DISA, or equivalent).
• Demonstrated experience managing subcontractors.
• Strong problem-solving skills and ability to work independently in a collaborative, cross-functional environment.
• Experience troubleshooting and supporting automated manufacturing equipment and process control systems.
• Strong interpersonal and communication skills (written and verbal).

Preferred Qualifications

• Project management experience overseeing subcontracted scope.
• Experience with cybersecurity Authorization to Operate (ATO) requirements and risk management framework (RMF).
• Familiarity with OT/IT network architecture, industrial cybersecurity principles, and SCADA/DCS/HMI platforms in a regulated production environment; experience with network segmentation and change management in a GMP setting.
• Experience supporting system commissioning, qualification, validation, and change control activities.
• Hands-on expertise with Allen-Bradley PLCs (ControlLogix, CompactLogix, MicroLogix) and Rockwell Automation software including RSLogix 5000 / Studio 5000, RSLogix 500, and FactoryTalk View SE/ME; experience with PanelView HMI configuration is a plus.
• Demonstrated experience with DeviceNet, Ethernet/IP, and other industrial communication protocols; ability to install, configure, and troubleshoot fieldbus networks and resolve device connectivity issues independently.