HVAC Subject Matter Expert
Mirus Consulting Group, Carolina, Carolina, United States
mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.
Position Summary The
HVAC Subject Matter Expert (SME)
will serve as the technical lead for HVAC and associated utility systems supporting GMP manufacturing operations. This role will provide technical oversight, troubleshooting, qualification, and lifecycle support for HVAC systems, ensuring they operate in a state of control, compliance, and reliability aligned with regulatory requirements and standards. The SME will play a critical role in startup activities, validation, environmental control, and continuous improvement, supporting both ongoing operations and capital projects. This position will also support commissioning, qualification (IQ/OQ/PQ), startup, and operational readiness of HVAC systems, while ensuring systems remain compliant and fit for use.
Key Responsibilities HVAC Technical Leadership / SME
Act as Subject Matter Expert (SME) for all HVAC systems (GMP and non-GMP) and associated utilities.
Provide technical support and decision-making for HVAC systems impacting manufacturing and environmental control.
Ensure systems operate within validated and controlled parameters.
Systems & Equipment Oversight.
Support and maintain critical HVAC and utility equipment including:
Air Handling Units (AHUs) (GMP classified areas, cleanrooms)
Air Chillers and Chilled Water Systems
Cooling towers
Boilers and heating systems
Pumps (circulation, condenser, chilled water)
HEPA filtration systems
Building Management Systems (BMS) / BAS
Compressed air and environmental control systems
Ductwork, dampers, VAV systems, and airflow controls
Validation & Qualification
SME support for commissioning, qualification, and validation activities (IQ/OQ/PQ) for HVAC systems.
Ensure systems remain in a validated state and compliant with cGMP.
Startup & Capital Projects
Knowledge and Support startup and commissioning activities for new or upgraded HVAC systems.
Act as user representative in capital projects, including design review, installation, and verification.
Coordinate with vendors, contractors, and internal teams.
Troubleshooting & Reliability
Lead complex troubleshooting and root cause analysis (RCA) for HVAC and utility systems.
Drive corrective and preventive actions (CAPA).
Improve system reliability using data analysis, KPIs, and trending.
Environmental & GMP Compliance
Ensure compliance with:
cGMP regulations
Environmental monitoring requirements
Cleanroom classifications and pressure differentials
Support:
Room pressure control
Temperature and humidity mapping
HEPA integrity testing
Environmental excursions investigations
Change Management & Quality Systems
Own or support:
Change Controls
Deviations and investigations
CAPA implementation
Assess impact of HVAC changes on validated systems and product quality.
Cross-Functional Coordination
Collaborate with:
Manufacturing
Quality Assurance
Engineering
Automation
Maintenance
Coordinate activities with vendors and contractors for installations and upgrades.
Continuous Improvement
Identify and implement process improvements and energy optimization initiatives.
Support capital planning and system upgrades.
Ensure alignment with Lilly engineering and industry standards.
Qualifications
Bachelor’s Degree in Mechanical Engineering (required)
5–10+ years of experience in HVAC systems within pharmaceutical or regulated environments
Strong experience with:
HVAC systems in GMP environments
Environmental control systems
Validation (IQ/OQ/PQ)
Experience in:
Startup and commissioning
Troubleshooting and RCA
Change Control, Deviations, CAPA
Knowledge of:
cGMP, FDA regulations
Cleanroom and environmental requirements
Preferred Qualifications
Experience in pharmaceutical manufacturing sites
Strong knowledge of:
BMS / BAS systems
Data trending and monitoring systems
Experience supporting:
API or sterile manufacturing environments
Six Sigma / Lean knowledge preferred
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
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Position Summary The
HVAC Subject Matter Expert (SME)
will serve as the technical lead for HVAC and associated utility systems supporting GMP manufacturing operations. This role will provide technical oversight, troubleshooting, qualification, and lifecycle support for HVAC systems, ensuring they operate in a state of control, compliance, and reliability aligned with regulatory requirements and standards. The SME will play a critical role in startup activities, validation, environmental control, and continuous improvement, supporting both ongoing operations and capital projects. This position will also support commissioning, qualification (IQ/OQ/PQ), startup, and operational readiness of HVAC systems, while ensuring systems remain compliant and fit for use.
Key Responsibilities HVAC Technical Leadership / SME
Act as Subject Matter Expert (SME) for all HVAC systems (GMP and non-GMP) and associated utilities.
Provide technical support and decision-making for HVAC systems impacting manufacturing and environmental control.
Ensure systems operate within validated and controlled parameters.
Systems & Equipment Oversight.
Support and maintain critical HVAC and utility equipment including:
Air Handling Units (AHUs) (GMP classified areas, cleanrooms)
Air Chillers and Chilled Water Systems
Cooling towers
Boilers and heating systems
Pumps (circulation, condenser, chilled water)
HEPA filtration systems
Building Management Systems (BMS) / BAS
Compressed air and environmental control systems
Ductwork, dampers, VAV systems, and airflow controls
Validation & Qualification
SME support for commissioning, qualification, and validation activities (IQ/OQ/PQ) for HVAC systems.
Ensure systems remain in a validated state and compliant with cGMP.
Startup & Capital Projects
Knowledge and Support startup and commissioning activities for new or upgraded HVAC systems.
Act as user representative in capital projects, including design review, installation, and verification.
Coordinate with vendors, contractors, and internal teams.
Troubleshooting & Reliability
Lead complex troubleshooting and root cause analysis (RCA) for HVAC and utility systems.
Drive corrective and preventive actions (CAPA).
Improve system reliability using data analysis, KPIs, and trending.
Environmental & GMP Compliance
Ensure compliance with:
cGMP regulations
Environmental monitoring requirements
Cleanroom classifications and pressure differentials
Support:
Room pressure control
Temperature and humidity mapping
HEPA integrity testing
Environmental excursions investigations
Change Management & Quality Systems
Own or support:
Change Controls
Deviations and investigations
CAPA implementation
Assess impact of HVAC changes on validated systems and product quality.
Cross-Functional Coordination
Collaborate with:
Manufacturing
Quality Assurance
Engineering
Automation
Maintenance
Coordinate activities with vendors and contractors for installations and upgrades.
Continuous Improvement
Identify and implement process improvements and energy optimization initiatives.
Support capital planning and system upgrades.
Ensure alignment with Lilly engineering and industry standards.
Qualifications
Bachelor’s Degree in Mechanical Engineering (required)
5–10+ years of experience in HVAC systems within pharmaceutical or regulated environments
Strong experience with:
HVAC systems in GMP environments
Environmental control systems
Validation (IQ/OQ/PQ)
Experience in:
Startup and commissioning
Troubleshooting and RCA
Change Control, Deviations, CAPA
Knowledge of:
cGMP, FDA regulations
Cleanroom and environmental requirements
Preferred Qualifications
Experience in pharmaceutical manufacturing sites
Strong knowledge of:
BMS / BAS systems
Data trending and monitoring systems
Experience supporting:
API or sterile manufacturing environments
Six Sigma / Lean knowledge preferred
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
#J-18808-Ljbffr