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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