Mechanical/HVAC Engineer

Jedson Engineering; San Juan (PR); On-site; USD 120,000 - 170,000; Full time

Job summary

Jedson Engineering seeks a Registered Professional Mechanical Engineer to lead HVAC design for pharmaceutical process facilities, including cleanrooms, labs and process suites. The role emphasizes cGMP awareness, contamination control, and coordination with process, automation and construction teams.

The ideal candidate has a strong background in cleanroom environments, aseptic processing, regulatory compliance, and experience supporting commissioning and qualification activities.

Qualifications

• Bachelor degree in Mechanical Engineering required.
• Active PE licensure is required.
• 10+ years in pharma/biotech or life sciences facilities.
• Experience with pharmaceutical HVAC, cleanrooms and aseptic processing.
• Experience supporting commissioning and qualification activities.
• Proficiency with design tools; AutoCAD/REVIT preferred.

Responsibilities

• Design and oversee HVAC systems for pharmaceutical manufacturing, labs, cleanrooms and process suites.
• Develop mechanical packages including load calculations and airflow strategies.
• Coordinate with process eng, validation, QA, automation and construction.
• Lead or support commissioning, qualification and validation activities.
• Review submittals, drawings, and calculations; drive energy efficiency improvements.
• Support audits, inspections, and regulatory reviews.

Skills

HVAC design

Cleanroom design

Aseptic manufacturing support

Building automation systems

Commissioning & qualification

Autocad/REVIT

Technical writing & coordination

Education

Bachelor degree in Mechanical Engineering

PE license

Tools

Autocad

REVIT

Job description

Mechanical Engineer (HVAC – Pharmaceutical Process Facilities)

We are seeking a Registered Professional Mechanical Engineer with strong HVAC design experience in pharmaceutical drug manufacturing environments. This role will lead and support the design of HVAC and mechanical systems for regulated facilities, including cleanrooms, laboratories, process suites, utility areas, and supporting infrastructure. The ideal candidate brings a strong understanding of cGMP environments, contamination control, pressurization strategies, and multidisciplinary coordination across process, architecture, automation, and construction.

The ideal candidate has a strong background in cleanroom environments, aseptic processing, contamination and control strategies, and regulatory compliance for pharmaceutical operations.

Key Responsibilities

• Design and oversee HVAC systems supporting pharmaceutical manufacturing, laboratories, cleanrooms and process suites
• Development of mechanical engineering packages including:
• HVAC load calculations
• Airflow and pressurization strategies
• Ductwork and piping layouts
• Equipment Specifications
• Control’s and integration requirements
• Ensure compliance with:
• cGMP Requirements
• FDA regulations
• ASHRAE guidelines
• USP requirements where applicable
• Support facility expansions, renovations, and capital projects from concept through commissioning and qualification
• Lead or support commissioning, qualification, and validation activities
• Coordinate with process engineering, validation, quality assurance, automation and manufacturing teams
• Perform root cause investigations and implement corrective actions related to HVAC or environmental excursions
• Review contractor submittals, drawings, and engineering calculations
• Provide technical leadership for energy efficiency and reliability improvements
• Support audits, inspections, and regulatory reviews

Required Qualifications

• Bachelor degree in Mechanical Engineering
• Active Professional Engineer (PE) registration/license required
• 10+ years of mechanical engineering experience in pharmaceutical, biotech, or life sciences facilities
• Demonstrated expertise with:
• Pharmaceutical HVAC systems
• Cleanroom Design
• Aseptic manufacturing support
• Building automation systems
• Experience supporting commissioning and qualification activities
• Proficiency with engineering design tools and autocad/REVIT preferred
• Excellent communication, technical writing, and project coordination skills

Preferred Qualifications

• Experience with sterile injectable or biologis manufacturing facilities
• Knowledge of containment systems and hazardous drug handling environments
• LEED accreditation or energy management experience
• Familiarity with risk-based contamination control strategies