Mechanical/HVAC Engineer

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