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.