Mechanical/HVAC Engineer

Estados Unidos

Cincinnati, Ohio, United States

Sobre a oportunidade

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

Idiomas

Mechanical/HVAC Engineer

Sobre a oportunidade

Key Responsibilities

Development of mechanical engineering packages including

Ensure compliance with

Required Qualifications

Demonstrated expertise with

Preferred Qualifications

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