Controls Engineer 3

The Senior Controls & Automation Engineer is responsible for leading and supporting manufacturing automation systems, process control improvements, and capital projects within a GMP manufacturing environment. This role serves as the Controls Subject Matter Expert (SME) for manufacturing operations, technical transfers, troubleshooting activities, process improvements, and regulatory inspections. The position works cross-functionally with Manufacturing, Engineering, Quality, Validation, and Technical Operations to ensure reliable operation of process automation systems while driving continuous improvement initiatives.

• Lead the planning, design, execution, and implementation of plant projects involving complex equipment modifications and significant process improvements.
• Serve as the Controls Lead for technology transfer projects, ensuring successful integration of automation systems into manufacturing operations.
• Support commissioning, qualification, and startup activities for new equipment and automation systems.
• Drive continuous improvement initiatives focused on reliability, performance, efficiency, and process robustness.

• Provide technical leadership and SME support for the design, operation, maintenance, and optimization of process automation systems and manufacturing equipment.
• Support resolution of equipment breakdowns, production issues, deviations, and product quality concerns related to automation systems.
• Conduct troubleshooting and root cause investigations for manufacturing process control systems, including PLCs, HMIs, SCADA systems, historians, and networked automation equipment.
• Analyze process and equipment performance using PI Historian data, control system trends, and automation analytics.
• Review, troubleshoot, and modify automation code and configurations as required.
• Participate in an on-call support rotation and provide technical support during off-hours as necessary.

• Initiate, manage, and support change controls throughout the full lifecycle, ensuring compliance with GMP and company requirements.
• Own and execute corrective and preventive actions (CAPAs) related to automation and controls systems.
• Support deviation investigations and implement corrective solutions.
• Review and approve SOPs, Functional Specifications, Work Instructions, and engineering documentation.
• Ensure all activities are performed in accordance with GMP, safety, quality, and regulatory requirements.

• Represent the Controls function in Integrated Project Teams (IPT), Joint Project Teams (JPT), and cross-functional meetings.
• Collaborate with Manufacturing, Facilities, Quality, Validation, and Engineering teams to support operational excellence.
• Provide technical guidance and training on automation systems to manufacturing and support personnel.

• Participate in internal audits, customer audits, and regulatory inspections as the Controls SME.
• Provide technical documentation and responses during audit and inspection activities.
• Ensure automation systems remain compliant with applicable regulatory requirements and data integrity standards.

• Perform all work safely and follow Environmental Health & Safety (EHS) requirements.
• Complete all required training and maintain qualifications relevant to assigned responsibilities.
• Remain current on industry best practices, emerging technologies, and company procedures.

• Bachelor's degree in Electrical Engineering, Chemical Engineering, Automation Engineering, Computer Engineering, or related technical discipline.
• 5+ years of experience supporting automation and process control systems in a regulated manufacturing environment.
• Experience with pharmaceutical, biotechnology, life sciences, or GMP manufacturing operations.
• Strong knowledge of PLC, HMI, SCADA, and Historian systems.
• Experience with troubleshooting automation systems and supporting manufacturing operations.
• Knowledge of change control, CAPA, deviation management, and GMP documentation practices.
• Excellent analytical, problem-solving, and communication skills.

• Experience with DeltaV, Rockwell Automation, Siemens, or other distributed control systems.
• Experience with OSIsoft PI Historian and process data analytics.
• Knowledge of GAMP 5, 21 CFR Part 11, and computerized system validation (CSV).
• Project management experience supporting capital projects and technical transfers.
• Experience supporting regulatory inspections (FDA, EMA, MHRA, etc.).