Reliability & Validation Lead, GMP Fulfillment Ops

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

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,