Engineering Associate

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.