Operations System Specialist

Greatjob; Greenwood (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Greatjob is seeking an Operations System Specialist to enhance equipment reliability and maintenance optimization within a GMP/FDA-regulated distribution setting. You will drive risk-based maintenance strategies, support commissioning/validation, and collaborate with facilities, maintenance, engineering, quality, and operations teams to ensure safe, efficient distribution operations.

The role emphasizes hands-on technical knowledge, structured documentation, and cross-functional collaboration,

Qualifications

• Bachelor's degree in Industrial, Mechanical, or Electrical Engineering (or equivalent).
• 5+ years of experience in facilities, equipment, or operations engineering with design/maintenance focus.
• Experience in FDA-regulated or GMP environments.
• Proficiency with Microsoft Office (Word, Excel, Outlook).
• Hands-on CMMS experience (MaintainX or equivalent).

Responsibilities

• Serve as SME for facilities and operational systems supporting fulfillment and business-critical operations.
• Support equipment change control through technical impact assessments and risk evaluations.
• Assess risks related to equipment modifications, maintenance interventions, contractor activities, and new equipment installations.
• Ensure equipment-related activities and documentation comply with quality systems and regulatory standards.
• Support commissioning, qualification, and validation of new or modified material handling equipment and processes.
• Maintain and improve reliability programs to maximize uptime of critical assets.
• Track and report KPIs, historical performance data, and reliability metrics.
• Oversee contractor work to ensure compliance with plans and standards.
• Provide technical documentation and engineering specifications for equipment design, qualification, and validation.

Skills

Equipment reliability

Risk assessment

GMP compliance

Documentation

Education

Bachelor's in Industrial/Mechanical/Electrical Engineering

Tools

CMMS MaintainX

AutoCAD

3D CAD tools

Job description

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 focuses on improving equipment availability, minimizing operational disruptions, ensuring regulatory compliance, and supporting the lifecycle management of material handling and automation systems.

The specialist will drive reliability improvements, support complex technical investigations, establish risk-based maintenance strategies, and contribute to commissioning and validation activities to ensure safe, efficient, and reliable distribution operations.

This role operates within an FDA-regulated, high-availability operational environment supporting fulfillment operations, critical business functions, and administrative areas. The specialist will collaborate cross-functionally with facilities and maintenance, engineering, quality, and operations teams, while overseeing contractors and supporting both daily operations and strategic projects. The position requires strong hands-on technical knowledge combined with structured documentation and compliance discipline.

Key Responsibilities

• Serve as Subject Matter Expert (SME) 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.
• 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 work performed by trade contractors to ensure compliance with plans, specifications, and regulatory standards
• Provide support for 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.
• Support commissioning, qualification, and validation activities using a risk-based approach.
• Provide change control support, including impact assessments for equipment and system changes.
• 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 both locally and remotely.
• S trong understanding of RCA, FMEA/PFMEA, equipment criticality assessments, and risk-based decision-making.
• 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.
• 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, detail-oriented, and capable of managing multiple priorities.
• Ability to collaborate effectively across engineering, quality, maintenance, and operations teams.

Qualifications & ExperienceMinimum:

• Bachelor's degree in Industrial, Mechanical, or Electrical Engineering (or equivalent technical experience).
• 5+ years of experience in facilities, equipment, or operations engineering with design and/or maintenance focus.
• Experience working in FDA-regulated or GMP environments.
• Proficiency with Microsoft Office tools (Word, Excel, Outlook).
• Hands-on experience with CMMS platforms (e.g., MaintainX or equivalent).

Preferred:

• Master's degree in Engineering or related technical discipline.
• Experience with medical device or pharmaceutical quality standards (ISO 13485, 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.