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.