Controls Engineer

We are seeking an experienced Controls Engineer / Automation SME to provide technical support for manufacturing operations, process automation systems, and complex equipment. This role will serve as a technical resource to operations and cross-functional teams, ensuring instrumentation and automation systems are designed, maintained, and operating effectively to meet production and quality requirements.

Key Responsibilities:

• Provide technical support for manufacturing operations, instrumentation, and process automation systems.
• Lead the planning and execution of plant projects involving complex equipment modifications, automation changes, and significant process improvements.
• Serve as the Controls Lead for technology transfers and equipment implementation projects.
• Support the resolution of equipment breakdowns, automation issues, and quality events within manufacturing areas.
• Provide subject matter expertise to Manufacturing and other functional teams regarding the design, operation, and troubleshooting of process automation equipment.
• Conduct troubleshooting and technical analysis of manufacturing equipment and automation systems, including process data analysis, PI data review, control logic/code troubleshooting, and system diagnostics.
• Participate in an on-call rotation to provide technical support outside of normal business hours.
• Represent Controls/Automation on cross-functional teams, including IPTs/JPTs and project meetings.
• Participate in regulatory audits and inspections as a Controls/Automation subject matter expert when required.
• Own and execute assigned CAPA actions through completion.
• Initiate and support change controls, including development, review, implementation, and closure.
• Review and provide technical input on SOPs, functional specifications, work instructions, and other controlled documentation.
• Maintain compliance with all required safety, training, and quality requirements.
• Stay current on assigned training and applicable technical standards and procedures.
• Perform other duties and projects as assigned.

Qualifications:

• 5-10 years of experience in Controls Engineering, Process Automation, Manufacturing Engineering, or a related discipline.
• Experience within a pharmaceutical, biotechnology, life sciences, or equivalent highly regulated manufacturing environment.
• Strong knowledge of industrial automation, instrumentation, and process control systems.
• Experience troubleshooting automation systems, control logic, equipment, and manufacturing processes.
• Experience supporting technology transfers, capital projects, equipment changes, or process improvements.
• Experience with PI/process data analysis and automation system diagnostics.
• Familiarity with CAPA, change control, SOPs, and other quality systems within a regulated manufacturing environment.
• Strong communication and cross-functional collaboration skills.
• Supervisory or project management experience is preferred.
• Ability to participate in an on-call rotation and provide support during off-hours as needed.