Job Description
Position Summary
The Mechatronics Engineer supports the design, integration, commissioning, and ongoing reliability of automated manufacturing equipment for a new manufacturing facility. This role bridges mechanical, electrical, and software/controls disciplines to ensure that automated production lines – including over-pouching machines, conveyor and material-handling systems, and automated visual inspection equipment – operate safely, reliably, and in compliance with cGMP requirements. The Mechatronic Engineer works cross-functionally with process, facilities, quality, and operations teams throughout equipment design, qualification, and startup.
Key Responsibilities
● Support the design, specification, and integration of mechatronic systems – mechanical, electrical, pneumatic, and controls – for the automated lines.
● Develop, program, and troubleshoot PLC, HMI, and SCADA control logic (e.g., Allen-Bradley/Rockwell Studio 5000, Siemens TIA Portal) for automated production equipment, integrating machine vision inspection systems with line and conveyor controls.
● Design and support conveyor and material-handling control logic, including demand-based diverting and per-lane accumulation buffer sequencing.
● Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new automated equipment, and support commissioning, qualification (IQ/OQ/PQ), and startup of production lines in a cGMP environment.
● Collaborate with process, facilities, and quality engineering to integrate utility system controls – including water treatment (RO/CEDI) and steam sterilization equipment – with the broader plant automation architecture.
● Diagnose and resolve mechanical, electrical, and controls-related equipment failures; lead root cause analysis and implement corrective and preventive actions to minimize downtime.
● Create and maintain equipment documentation, including control narratives, wiring diagrams, PLC code documentation, and SOPs governing the operation and maintenance of automated equipment.
● Support development of preventive maintenance programs and spare-parts strategies for mechatronic and automated production equipment.
● Partner with equipment vendors throughout design review, procurement, factory testing, installation, and warranty support.
● Support pre-operational readiness activities, including facility walkthroughs and equipment qualification checklists, ahead of plant startup.
● Ensure all work complies with cGMP, safety, and applicable regulatory requirements (e.g., FDA, OSHA).
Qualifications
Education & Experience
● Bachelor's degree in Mechatronics Engineering, Electrical Engineering, Mechanical Engineering, Controls Engineering, or a related discipline (or equivalent combination of education and experience).
● 3–5+ years of experience in automation, controls, or mechatronics engineering, ideally within a pharmaceutical, medical device, or other regulated cGMP manufacturing environment.
Technical Skills
● PLC programming and troubleshooting (Allen- Bradley/RSLogix/Studio 5000, Siemens TIA Portal, or equivalent platforms).
● HMI/SCADA development, configuration, and troubleshooting.
● Machine vision system integration and configuration (e.g., automated visual inspection platforms).
● Working knowledge of servo motion control, variable frequency drives (VFDs), sensors, and pneumatics.
● Ability to read and troubleshoot electrical schematics, control panel wiring, and P&IDs.
● Familiarity with conveyor and material-handling system design, including diverter and buffering logic.
● Knowledge of GMP documentation and validation practices (IQ/OQ/PQ, change control, deviation investigation).
● CAD/mechanical design familiarity (SolidWorks, AutoCAD) is a plus.
Other Requirements
● Strong analytical and root-cause troubleshooting skills across mechanical, electrical, and software domains.
● Ability to work cross-functionally with engineering, quality, facilities, and operations teams.
● Clear written and verbal communication skills, including technical documentation.
● Willingness to work on or near the production floor, with some off-shift support required during commissioning and startup activities.
● Ability to lift 25–50 lbs., and to stand, walk, and move throughout a manufacturing environment for extended periods.
Preferred Qualifications
● Experience with over-pouching, form-fill-seal, or other pharmaceutical packaging line automation.
● Experience with water treatment or utility system controls (e.g., RO/CEDI systems, steam sterilizers).
● Experience with Fanuc Robots an asset.
● Exposure to Lean Manufacturing or Six Sigma methodologies.
● Experience supporting new facility startups or greenfield manufacturing projects.
\nCompany DescriptionIVS Health Care Utility, Inc. (IVS) is building a new manufacturing plant from the ground up, spanning engineering, facilities, quality, workforce planning, and regulatory compliance. The company is standing up a full cGMP manufacturing operation — from high-speed over-pouching and conveyor line design to water treatment systems, automated inspection, warehouse logistics, and a workforce built to run it all — with the goal of delivering high-quality products through a facility engineered for reliability and patient safety.
IVS Health Care Utility, Inc. (IVS) is building a new manufacturing plant from the ground up, spanning engineering, facilities, quality, workforce planning, and regulatory compliance. The company is standing up a full cGMP manufacturing operation — from high-speed over-pouching and conveyor line design to water treatment systems, automated inspection, warehouse logistics, and a workforce built to run it all — with the goal of delivering high-quality products through a facility engineered for reliability and patient safety.
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