Duties
- Project Planning & Execution:
Lead the design, development, and implementation of HVAC projects for new and existing biotech manufacturing areas, ensuring compliance with all relevant regulatory standards, including cGMP, FDA, and ISO guidelines.
- System Design & Optimization:
Design and develop HVAC systems to meet the environmental control needs of clean rooms, laboratories, and manufacturing spaces.
Optimize airflow, temperature, humidity, and filtration levels to achieve precise environmental conditions for sensitive processes.
- Compliance & Documentation:
Develop and maintain documentation for all HVAC systems, including design specifications, SOPs, validation protocols, and maintenance records, to meet regulatory and quality compliance.
Manage project budgets, timelines, and resources. Coordinate with internal teams, contractors, and vendors to ensure projects are delivered on time and within scope.
- Technical Troubleshooting:
Provide hands-on support for troubleshooting and resolving issues with HVAC equipment and systems, minimizing downtime and ensuring reliability for critical manufacturing areas.
Oversee commissioning, validation, and qualification activities (IQ/OQ/PQ) for new or modified HVAC systems. Conduct performance testing to ensure system efficacy and adherence to industry standards.
- Cross-functional Collaboration:
Work closely with process engineers, quality assurance, safety, and operations teams to understand environmental requirements and incorporate them into HVAC system designs and projects.
Identify opportunities to enhance energy efficiency, reliability, and operational performance of HVAC systems. Implement best practices and new technologies as appropriate.