Automation Engineer

This is a full time position, reporting to the Associate Director of Automation Engineering. The Automation Engineer supports, maintains, and enhances Operational Technology (OT) and Process Automation Systems across GMP manufacturing operations within a CDMO environment. This role focuses on PLC/HMI troubleshooting, system integration, data acquisition, BMS support, and ensuring high equipment reliability in compliance with cGMP, internal quality standards, and regulatory requirements.

The ideal candidate has strong hands-on experience with platforms such as Ignition, AVEVA PI (OSI PI), DeltaV, Rockwell Automation (Control Logix/Factory Talk), SQL databases, and Building Management Systems (BMS). This position plays a key role in ensuring automation systems support robust, efficient, and compliant manufacturing processes.

• Provide day-to-day support for Operational Technology (OT) systems in GMP manufacturing facilities.
• Diagnose, troubleshoot, and correct issues with PLCs, HMIs, SCADA systems, and control hardware.
• Perform change management, testing, and documentation of automation changes per GMP and internal quality processes.
• Maintain high system availability and reliability across automation platforms and networks.
• Develop, modify, and maintain PLC and HMI code using Rockwell Automation and/or other industrial control platforms.
• Support configuration, optimization, and troubleshooting of DeltaV distributed control systems.
• Implement enhancements and corrective actions for Ignition SCADA deployments, including tags, scripts, and visualization components.

• Configure and maintain AVEVA PI (OSI PI) historian infrastructure, interfaces, tags, notifications, and reporting.
• Support SQL-based reporting tools, dashboards, data analytics, and automation system integrations.
• Ensure data integrity, availability, and compliance with regulatory expectations.

• Support Building Management Systems (BMS) and environmental monitoring controls.
• Integrate automation equipment and instrumentation with MES, historian, and SCADA platforms.
• Coordinate with vendors, integrators, and equipment suppliers to deliver fully integrated and validated control solutions.

• Execute changes through formal change control processes and generate required technical documentation.
• Support commissioning, qualification, validation, and periodic review of automation systems.
• Participate in investigations, CAPAs, and deviations related to automation or OT system performance.
• Ensure all automation activities comply with cGMP, 21 CFR Part 11, data integrity, and CDMO regulatory standards.
• Assist in implementing automation improvement initiatives, upgrades, and lifecycle management projects.
• Support site expansions, equipment onboarding, and new manufacturing technologies.
• Collaborate cross-functionally with Manufacturing, Facilities, Quality, IT, and external vendors.

• Bachelor’s degree in Engineering (Electrical, Automation, Chemical, Mechanical) or related technical field; equivalent industry experience considered.
• 3–7 years of automation/OT experience in a GMP-regulated biopharma, pharmaceutical, or CDMO environment.
• Hands-on experience with:
• Rockwell Automation (Control Logix, Factory Talk View/SE/ME)
• DeltaV DCS ( at least 1 year of experience)
• Ignition SCADA
• AVEVA PI / OSIsoft PI historian
• SQL and relational database systems
• BMS platforms and environmental controls
• Strong understanding of 21 CFR Part 11, data integrity, GAMP, and GMP quality expectations.
• Experience with industrial communication protocols (Ether Net/IP, Modbus, Profibus, OPC/OPC UA).
• Ability to troubleshoot field instrumentation, control panels, I/O wiring, and automation networks.
• Excellent communication, documentation, and cross-functional problem-solving skills.
• Ability to work on-call or off-hours as needed for automation support.
• Ability to coordinate with vendors, integrators, and contractors.
• Strong analytical skills and ability to interpret P&IDs, control narratives, and electrical schematics.

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.