OverviewTechnical & Engineering Consulting is seeking an experienced HVAC Systems Utilities Engineer to support pharmaceutical manufacturing operations and capital projects. The selected candidate will serve as the site subject matter expert (SME) for HVAC systems and provide engineering support for critical utilities including chillers, compressors, cooling towers, air handling units (AHUs), and cleanroom environmental control systems.
This position requires strong technical expertise in GMP-regulated environments, cleanroom HVAC design, qualification, troubleshooting, and project execution.
Key ResponsibilitiesHVAC & Utilities Engineering- Serve as the technical lead for HVAC systems supporting manufacturing and cleanroom operations.
- Perform psychrometric analysis, airflow calculations, and heat load assessments.
- Support design, operation, and optimization of cleanroom HVAC systems.
- Manage pressure cascades, air change rates (ACH), airflow strategies, temperature, humidity, and differential pressure controls.
- Provide technical oversight for AHUs, HEPA/ULPA filtration systems, dampers, humidification systems, and chilled water integration.
- Support utilities systems including chillers, cooling towers, compressors, and associated distribution networks.
Compliance & Validation- Ensure compliance with FDA, cGMP, and applicable regulatory requirements.
- Support HVAC and utility equipment qualification activities (IQ/OQ/PQ).
- Participate in requalification, change control, Environmental Monitoring (EM), and Contamination Control Strategy (CCS) programs.
- Apply industry standards including ISO 14644, EU GMP Annex 1, and ISPE Baseline Guides.
Engineering Projects- Develop User Requirements Specifications (URS), Project Charters, and CAPEX business cases.
- Participate in design reviews and approve P&IDs.
- Develop and execute FAT and SAT protocols.
- Support startup, commissioning, qualification, and automation activities.
- Conduct risk assessments (FMEA) and support continuous improvement initiatives.
- Develop maintenance strategies, spare parts plans, and job plans.
Operations Support- Provide daily technical support to manufacturing and facilities operations.
- Lead troubleshooting efforts for HVAC and utility-related issues.
- Conduct root cause investigations and implement corrective actions.
- Review and interpret TAB reports and filter integrity testing results (DOP/PAO).
- Define return-to-service requirements following maintenance activities.
- Develop, review, and update SOPs and operating procedures.
Required Qualifications- Bachelor's Degree in Mechanical Engineering, Chemical Engineering, or related engineering discipline.
- Minimum 5+ years of experience supporting HVAC systems in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.
- Strong knowledge of:
- Cleanroom HVAC systems
- Air handling units (AHUs)
- Chillers, cooling towers, and compressors
- Building Management Systems (BMS)
- HVAC qualification and validation
- cGMP and regulatory requirements
- Experience with P&IDs, engineering documentation, and project execution.
- Demonstrated troubleshooting and root cause analysis skills.
Preferred Qualifications- Knowledge of ISO 14644 and EU GMP Annex 1 requirements.
- Experience with FAT/SAT, commissioning, and startup activities.
- ASHRAE certification.
- LEED certification.
- ISPE pharmaceutical engineering training or certification.
Desired Skills- Strong technical leadership and communication skills.
- Ability to work independently and cross-functionally.
- Excellent problem-solving and analytical capabilities.
- Experience managing multiple priorities in a fast-paced manufacturing environment.
Work EnvironmentThis position supports pharmaceutical manufacturing and utilities operations and may require field work, equipment walkdowns, troubleshooting activities, and support during project startup and qualification phases.
