Project Manager III
Katalyst CRO
Job Description
Provide engineering support for Heating, Ventilation, and Air Conditioning (HVAC) systems to ensure reliable, compliant, and efficient operation of facility and manufacturing environments. This role supports operations, maintenance, and capital projects within Utilities and Facilities Engineering. HVAC systems are critical for controlling temperature, humidity, airflow, cleanliness, and pressure, which directly impacts product quality and regulatory compliance in pharmaceutical environments.
Provide engineering support for Heating, Ventilation, and Air Conditioning (HVAC) systems to ensure reliable, compliant, and efficient operation of facility and manufacturing environments. This role supports operations, maintenance, and capital projects within Utilities and Facilities Engineering. HVAC systems are critical for controlling temperature, humidity, airflow, cleanliness, and pressure, which directly impacts product quality and regulatory compliance in pharmaceutical environments.
Responsibilities
Technical & Engineering
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.
Operations Support
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).
Automation & Controls (Client Integration)
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.
Projects & Continuous Improvement
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.
Compliance & Documentation
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
Requirements
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.
Skills & Competencies
Strong understanding of:
HVAC system design and operation.
Cleanroom and controlled environments.
Client/controls systems.
Problem-solving and troubleshooting capability.
Ability to manage multiple projects and priorities.
Strong collaboration with operations, quality, and maintenance teams.
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