Engineering Associate
Tailstorm Health Inc
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.
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.
Requirements
- 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.
- Exposure to HVAC systems, facility maintenance, utilities, calibration, or validation.
- Experience with GMP documentation and regulated manufacturing environments.
Company overview
Tailstorm Health Inc is a pharmaceutical manufacturing company operating in the healthcare sector. As a pharmaceutical organization, the company is involved in the research, development, and production of medicinal drugs and therapeutic products. Pharmaceutical companies like Tailstorm Health play a crucial role in the healthcare ecosystem by creating innovative treatments for various medical conditions, conducting clinical trials, and ensuring regulatory compliance for drug safety and efficacy. The company's operations likely encompass drug discovery, formulation development, manufacturing processes, quality control, and distribution of pharmaceutical products to healthcare providers and patients. In the competitive pharmaceutical landscape, companies must navigate complex regulatory environments, intellectual property considerations, and market dynamics while maintaining high standards for product quality and patient safety.