Senior HVAC & GMP Quality Engineer (Pharma)

FITS, LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

FITS, LLC in Puerto Rico seeks an Engineering professional for Project Management in the pharmaceutical/regulated industry. The role focuses on optimizing chilled water systems, cooling towers and HVAC, with emphasis on quality systems and regulatory alignment.

Responsibilities include evaluating maintenance plans, supporting deviations, CAPAs, change controls, and coordinating with vendors and internal teams to meet safety, quality, and schedule targets.

Qualifications

• Bachelor’s degree in engineering with at least 8 years of experience in pharma or regulated industry.
• Specialized expertise in industrial chilled water systems, cooling towers, and HVAC.
• Shift: Administrative and as needed by business.
• Experience with OEFM electronic forms or similar quality and facilities-management systems.
• Experience managing pest-control programs within a regulated manufacturing environment.
• Knowledge of Deviations, CAPA, Change Controls, and controlled documentation.

Responsibilities

• Evaluate and optimize preventive and predictive maintenance plans for HVAC and cooling systems.
• Provide primary support for Quality Systems activities (deviations, CAPAs, change controls) and maintain inspection-ready records.
• Investigate and document deviations following SOPs; drive CAPAs to closure with Quality team.
• Support creation and tracking of OEFM electronic forms across functions.
• Coordinate pest control program transformation with vendors and stakeholders.
• Maintain records to support regulatory inspections of facilities and utilities.
• Supervise contractors and review work on operations and capital projects.
• Serve as a technical expert in chilled water, cooling towers, and HVAC with established methodologies.
• Collaborate with project managers, consultants, and engineering firms to deliver design/engineering projects on schedule and budget.

Skills

HVAC systems

Chilled water

Cooling towers

Quality Systems

CAPA Management

Change Controls

Regulatory knowledge

Vendor coordination

Education

Bachelor's degree in Engineering

Tools

OEFM electronic forms

Job description

FITS, LLC in Puerto Rico seeks an Engineering professional for Project Management in the pharmaceutical/regulated industry. The role focuses on optimizing chilled water systems, cooling towers and HVAC, with emphasis on quality systems and regulatory alignment.

Responsibilities include evaluating maintenance plans, supporting deviations, CAPAs, change controls, and coordinating with vendors and internal teams to meet safety, quality, and schedule targets.