Note: The job is a remote job and is open to candidates in USA. Katalyst CRO is a company focused on engineering support for HVAC systems in pharmaceutical environments. They are seeking a Project Manager III to provide engineering support, ensure compliance, and lead capital projects related to HVAC systems.
Responsibilities
- Design, review, and modify HVAC systems, including
- Air Handling Units (AHUs), ducting, and airflow systems
- Heating, cooling, humidification, and filtration systems
- Perform engineering calculations (airflow, load, pressure, energy)
- Ensure compliance with GMP, GEP, and site standards for controlled environments
- Review and approve HVAC-related drawings, specifications, and change records
- Support system commissioning, qualification, and requalification
- Provide troubleshooting support for HVAC system failures or deviations
- Analyze system performance issues (e.g., airflow imbalance, temperature instability)
- Work closely with maintenance and operations teams to resolve issues in real time
- Participate in on-call or off-hours support when required (common in utilities roles)
- Support HVAC systems integrated with Building Automation Systems (Client), including
- Monitoring alarms and trends
- Troubleshooting system malfunctions
- Reviewing and implementing automation changes
- HVAC systems are commonly monitored via Client platforms (e.g., Siemens Desigo), which also handle site utility alarms and regulatory monitoring
- Lead or support capital projects and upgrades (retrofits, expansions, efficiency improvements)
- Identify energy and sustainability opportunities (e.g., airflow optimization, heat recovery)
- Support retro commissioning efforts to improve system performance and reliability
- Assist in developing and executing project scopes, timelines, and budgets
- Ensure HVAC systems meet regulatory and quality requirements (FDA, GMP)
- Support audits, inspections, and deviation investigations
- Develop and maintain
- SOPs and engineering standards
- Change controls and validation documentation
- Provide technical input for permits and safety reviews
Skills
- Bachelor's degree in Mechanical Engineering or related field
- Typically 3–8+ years in HVAC engineering or utilities systems
- Strong understanding of HVAC system design and operation
- Strong understanding of Cleanroom and controlled environments
- Strong understanding of Client/controls systems
- Problem-solving and troubleshooting capability
- Ability to manage multiple projects and priorities
- Strong collaboration with operations, quality, and maintenance teams
- Experience in pharmaceutical, biotech, or regulated environments preferred
Company Overview
Company H1B Sponsorship