Operations System Specialist

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., * 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.
• Strong 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., * 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.