Engineering Associate

RXinsider LTD.; Chandler, Northern (AZ, KY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

RXinsider LTD. in Chandler, AZ is seeking an Engineering Associate to support maintenance, reliability, and compliance for a GMP sterile manufacturing facility.

You will perform preventive maintenance, assist with troubleshooting, and maintain GMP-compliant documentation to minimize downtime. The role requires a Bachelor's in Mechanical, Electrical, or Instrumentation Engineering and 0–2 years of pharma or regulated manufacturing experience.

Qualifications

• Bachelor's degree in Mechanical, Electrical, or Instrumentation Engineering.
• 0–2 years of experience in pharmaceutical or regulated manufacturing environments.
• Basic understanding of cGMP principles.
• Strong technical documentation, communication, and problem-solving skills.
• Proficiency in Microsoft Office applications.

Responsibilities

• Perform scheduled preventive maintenance on equipment, facilities, HVAC, and utilities.
• Conduct inspections, lubrication, adjustments, and replacement of worn components.
• Support equipment reliability and minimize downtime.
• Maintain facility infrastructure, cleanrooms, HVAC systems, and environmental controls.
• Monitor system performance and coordinate corrective actions when required.
• Troubleshoot equipment and utility issues.
• Complete maintenance records, PM documentation, and work orders in compliance with GDP and cGMP requirements.
• Support calibration, qualification, and audit readiness activities.
• Provide engineering support to Manufacturing, QA, QC, and Validation teams.
• Ensure critical systems are operational to support uninterrupted production.
• Maintain safety and regulatory compliance during all maintenance activities.

Skills

Technical documentation

Communication

Problem solving

Microsoft Office

Education

Bachelor's degree in Mechanical, Electrical, or Instrumentation Engineering

Tools

Microsoft Office

Job description

Position Summary

The Engineering Associate supports maintenance, reliability, and compliance of manufacturing equipment, facility systems, HVAC, and critical utilities within a 503B sterile injectable manufacturing facility. This role executes preventive maintenance, supports troubleshooting, maintains GMP-compliant documentation, and helps ensure uninterrupted manufacturing operations.

Key Responsibilities

Preventive Maintenance & Reliability

• Perform scheduled preventive maintenance on equipment, facilities, HVAC, and utilities.
• Conduct inspections, lubrication, adjustments, and replacement of worn components.
• Support equipment reliability and minimize downtime.

Facility, HVAC & Utilities Support

• Maintain facility infrastructure, cleanrooms, HVAC systems, and environmental controls.
• Support operation and maintenance of WFI, DI/RO, compressed air, and nitrogen systems.
• Monitor system performance and coordinate corrective actions when required.

Troubleshooting & Compliance

• Troubleshoot equipment and utility issues.
• Complete maintenance records, PM documentation, and work orders in compliance with GDP and cGMP requirements.
• Support calibration, qualification, and audit readiness activities.

Production & Cross-Functional Support

• Provide engineering support to Manufacturing, QA, QC, and Validation teams.
• Ensure critical systems are operational to support uninterrupted production.
• Maintain safety and regulatory compliance during all maintenance activities.

Qualifications

Required

• Bachelor's degree in Mechanical, Electrical, or Instrumentation Engineering.
• 0–2 years of experience in pharmaceutical or regulated manufacturing environments. Fresh graduates are welcome.
• Basic understanding of cGMP principles.
• Strong technical documentation, communication, and problem-solving skills.
• Proficiency in Microsoft Office applications.

Preferred

• Exposure to HVAC systems, facility maintenance, utilities, calibration, or validation.
• Experience with GMP documentation and regulated manufacturing environments.

Key Competencies

• Preventive Maintenance
• Equipment Troubleshooting
• HVAC & Utilities Maintenance
• GMP Documentation
• Technical Problem Solving
• Safety & Compliance
• Cross-Functional Collaboration
• Attention to Detail
• Continuous Learning

What Success Looks Like

• PM activities completed on time and accurately.
• Reduced equipment downtime and improved reliability.
• Accurate, audit-ready maintenance documentation.
• Consistent compliance with GMP and safety requirements.
• Reliable support for manufacturing operations and facility systems.