Mechanical/HVAC Engineer
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
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 submittmits, drawings, and engineering calculations
- Provide technical leadership for energy efficiency and reliability improvements
- Support audits, inspections, and regulatory reviews
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What This Job Offers
Job Type
Full-time
Career Level
Senior
