Operations System Specialist

Resmed•Greenwood, IN

About The Position

The Operations System Specialist provides technical expertise in equipment reliability, maintenance optimization, risk management, and qualification and validation of operational systems within distribution centers. The role aims to improve equipment availability, minimize operational disruptions, ensure regulatory compliance, and support lifecycle management of material handling and automation systems. The specialist drives reliability improvements, supports complex technical investigations, establishes risk-based maintenance strategies, and contributes to commissioning and validation activities to ensure safe, efficient, and reliable distribution operations. The role operates in an FDA-regulated, high-availability environment supporting fulfillment operations, critical business functions, and administrative areas. It works cross-functionally with facilities and maintenance, engineering, quality, and operations teams; oversees contractors; and supports daily operations and strategic projects. The position combines hands-on technical knowledge with structured documentation and compliance discipline.

Requirements

Bachelor's degree in Industrial, Mechanical, or Electrical Engineering, or equivalent technical experience.
At least 5 years of experience in facilities, equipment, or operations engineering with a design and/or maintenance focus.
Experience working in FDA-regulated or GMP environments.
Proficiency with Microsoft Office tools, including Word, Excel, and Outlook.
Hands-on experience with CMMS platforms such as MaintainX or equivalent.
Strong technical knowledge of mechanical, electrical, and automation systems within facilities and operations.
Hands-on expertise with HVAC, BMS/EMS, electrical distribution, and plant support systems.
Advanced troubleshooting skills for PLCs, industrial networks, motor controls, servo drives, and VFDs.
Strong understanding of commissioning, qualification, and validation in GMP-regulated environments.
Ability to interpret construction drawings, schematics, and blueprints.
Proficiency in CMMS platforms and asset lifecycle management.
Experience with AutoCAD and 3D CAD tools.
Strong analytical, problem-solving, and root cause analysis skills.
Excellent written and verbal communication skills, including technical documentation.
Highly organized and detail-oriented, with the ability to manage multiple priorities.
Ability to collaborate effectively across engineering, quality, maintenance, and operations teams.
Strong understanding of RCA, FMEA/PFMEA, equipment criticality assessments, and risk-based decision-making.

Nice To Haves

Master's degree in Engineering or a related technical discipline.
Experience with medical device or pharmaceutical quality standards, including ISO 13485 and 21 CFR 820.
Demonstrated experience developing validation master plans, protocols, and reports.
Experience supporting automation, material handling, and fulfillment operations.
Strong understanding of design, construction, and contracting processes.

Responsibilities

Serve as the subject matter expert for facilities and operational systems supporting fulfillment and business-critical operations.
Support equipment change control through technical impact assessments, risk evaluations, and identification of verification or revalidation requirements.
Assess risks associated with equipment modifications, maintenance interventions, contractor activities, and new equipment installations.
Ensure equipment-related activities and documentation align with applicable quality management system requirements and regulatory standards.
Support commissioning, qualification, and validation of new or modified material handling equipment, automation systems, and operational processes using a risk-based approach.
Maintain and improve reliability systems and programs to maximize uptime of critical assets.
Track, analyze, and report operational KPIs, historical performance data, and reliability metrics.
Oversee and inspect trade contractor work for compliance with plans, specifications, and regulatory standards.
Support equipment design, modification, and performance optimization initiatives.
Develop technical procedures, maintenance standards, troubleshooting guides, performance dashboards, and engineering documentation.
Generate engineering specifications and technical documentation for equipment design, qualification, and validation.
Troubleshoot material handling and automation control systems, including PLC/PC controllers, industrial networks, drives, motors, and electrical distribution systems.
Provide escalation and after-hours technical support to onsite automation, locally and remotely.
Act as a key technical stakeholder supporting regional and cross-functional initiatives.
Provide reports and presentations on proposed projects, system performance, and operational improvements.
Deliver daily operational support as needed to ensure system availability and regulatory compliance.