Automation Engineer

Essential Functions

• Provide support for the design, start-up, maintenance, and continuous improvement of automation systems for Leiters production and facilities.
• Provides first-line troubleshooting and technical support for PLCs and HMIs on production equipment to the Maintenance and Manufacturing departments.
• Supports investigations and deviations involving production, facilities, and packaging equipment issues.
• Supports integration between PLC/SCADA layers and higher level systems.
• Responsible for acting as a technical resource to the engineering, maintenance, operations, and validation departments.
• Serves as technical representative regarding automation to external suppliers and support vendors.
• Supports configuration and verification of new process instrumentation and control systems, complete with adequate documentation.
• Programs PLC’s and ladder diagram troubleshooting.
• Supports IQ/OQ/PQ documentation, Deviation Investigations, CAPAs, FAT and SAT.
• Ensures all company and site Engineering policies and procedures are adhered to.
• Ensures automated systems are in compliance with federal and state GMP guidelines, site procedures, life-cycle document reviews, training, user access, and audit trail reviews.
• Performs any other activities as directed by the VP Facilities and Engineering.
• Leads consistently in productivity, quality, and teamwork metrics.
• Adheres to all applicable procedures, CGMPs, company policies, and any other quality or regulatory requirements (e.g., OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).

Experince and Necessary Skills

• Bachelor’s degree in Electrical, Mechanical, Computer Automation/Controls Engineering or relevant fields preferred.
• At least 2 years of experience in a highly regulated environment like biotechnology, pharmaceutical, or related fields, including a significant exposure to regulatory requirements.
• Working knowledge of PLC programming concepts on one major platform (Rockwell Automation Studio 5000 preferred).
• Familiarity with at least one HMI/SCADA platform (Ignition preferred).
• Experience in troubleshooting industrial sensors, vision systems, robotics.
• Knowledge of cGMP requirements as they pertain to the automation of manufacturing and lab equipment in an aseptic filling pharmaceutical environment.