Senior HVAC Project Lead - GMP/Pharma

Katalyst CRO; Vacaville (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO in California is seeking an experienced HVAC Engineer to provide engineering support for HVAC systems in pharmaceutical environments, ensuring reliable, compliant, and efficient operation of facility and manufacturing spaces.

The role covers technical engineering design, operations support, automation & controls, and continuous improvement, collaborating with maintenance, quality, and production teams to meet GMP and regulatory standards.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• Typically 38+ years in HVAC engineering or utilities systems.
• Experience in pharmaceutical, biotech, or regulated environments preferred.

Responsibilities

• Design, review, and modify HVAC systems, including Air Handling Units (AHUs), ducting, and airflow 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 and reviewing automation changes.
• 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

HVAC design

Cleanroom environments

Client/controls systems

Troubleshooting

Project management

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Job description

Katalyst CRO in California is seeking an experienced HVAC Engineer to provide engineering support for HVAC systems in pharmaceutical environments, ensuring reliable, compliant, and efficient operation of facility and manufacturing spaces.

The role covers technical engineering design, operations support, automation & controls, and continuous improvement, collaborating with maintenance, quality, and production teams to meet GMP and regulatory standards.