Controls Engineer

Essential Responsibilities and Duties

• Design, program, troubleshoot, and maintain PLC-based control systems to minimize downtime.
• Develop and modify HMI and SCADA applications to support manufacturing operations.
• Support process equipment including humidifiers, chillers, HVAC, refrigerators, freezers, autoclaves, and incubators.
• Analyze process trends and identify opportunities for continuous improvement.
• Apply standard practices and techniques in solving problems related to facilities operation and automated support systems.
• Investigate deviations and implement corrective and preventive actions (CAPA).
• Contribute data/findings for use in technical reports, documents, or oral/written presentations.
• Support CSV (Computer System Validation) activities in accordance with FDA regulations and GAMP 5 guidelines.
• Prepare and execute User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and commissioning protocol and report.
• Apply 21 CFR Part 11 requirements for electronic records and signatures.
• Manage change controls and engineering records.
• Ensure version control of automation software and configurations.
• Maintain control system documentation, network diagrams, and software backups.
• Support facility audits and regulatory inspections.
• Collaborate cross functionally with various teams as required.
• Coordinate with equipment vendors, integrators, contractors, and internal stakeholders and oversee their on-site activities.
• Perform minor repair work in one or more of the following areas: electrical, building utilities, and HVAC.
• Oversee preventative maintenance and calibration schedules of GMP manufacturing, laboratory, and utility equipment in accordance with OEM recommendations and internal SOPs as Equipment Coordinator.
• Document and maintain records of Out Of Service tags, Non-Routine Maintenance, and work performed by external contracts.
• Respond to building management and environmental monitoring system alarms.
• Adhere to gowning requirements for Classified Areas of the facility (ISO 7 and 8 sterile gowning).
• Rotating weekend/after-hours availability for on-call alarm monitoring and support.
• Other duties as assigned.

Required Qualifications

• Bachelor's Degree or higher in Electrical Engineering, Controls/Computer Engineering, Mechanical Engineering with Automation focus, or related discipline.
• 3-5 years of work experience in GMP facility, mechanical, electrical, or other regulated manufacturing environments.
• Experience in pharmaceutical, biotechnology, medical device, or life sciences industries preferred.
• Experience with AutoCAD and MS Office.
• Ability to read Electrical schematics, P&IDs, and automated code.
• Ability to write SQL code.
• Must have experience with PLC Platforms (i.e. Rockwell Allen-Bradley ControlLogix) and HMI/SCADA (i.e. Factory Talk View and Niagara (HVAC)).
• Must be comfortable working within Industrial Networks (i.e. Ethernet/IP, Modbus TCP/IP/RS 485, Backnet/Lonworks, and ISO-14644).
• Knowledge of relevant regulations and Good Engineering Practices.
• Strong verbal and written communication skills.
• Project management skills, with ability to manage multiple projects simultaneously.
• Strong analytical and troubleshooting skills.
• Excellent technical writing and documentation abilities.
• Demonstrated commitment to safety, quality, and regulatory compliance.
• Ability to work effectively in cross-functional teams.