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.
