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
ISO cleanroom standards
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
Environmental Control systems
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
