Mechanical/HVAC Engineer
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 ResponsibilitiesDesign and oversee HVAC systems supporting pharmaceutical manufacturing, laboratories, cleanrooms and process suitesDevelopment of mechanical engineering packages including:HVAC load calculationsAirflow and pressurization strategiesDuctwork and piping layoutsEquipment SpecificationsControl's and integration requirementsEnsure compliance with:cGMP RequirementsFDA regulationsISO cleanroom standardsASHRAE guidelinesUSP requirements where applicableSupport facility expansions, renovations, and capital projects from concept through commissioning and qualificationLead or support commissioning, qualification, and validation activitiesCoordinate with process engineering, validation, quality assurance, automation and manufacturing teamsPerform root cause investigations and implement corrective actions related to HVAC or environmental excursionsReview contractor submittals, drawings, and engineering calculationsProvide technical leadership for energy efficiency and reliability improvementsSupport audits, inspections, and regulatory reviewsRequired QualificationsBachelor degree in Mechanical EngineeringActive Professional Engineer (PE) registration/license required10+ years of mechanical engineering experience in pharmaceutical, biotech, or life sciences facilitiesDemonstrated expertise with:Pharmaceutical HVAC systemsCleanroom DesignAseptic manufacturing supportEnvironmental Control systemsBuilding automation systemsExperience supporting commissioning and qualification activitiesProficiency with engineering design tools and autocad/REVIT preferredExcellent communication, technical writing, and project coordination skillsPreferred QualificationsExperience with sterile injectable or biologis manufacturing facilitiesKnowledge of containment systems and hazardous drug handling environmentsLEED accreditation or energy management experienceFamiliarity with risk-based contamination control strategies