Gandiv Insights LLC · 15 hours ago
HVAC Validation Engineer (Pharma / GMP)
Cambridge, MA
Contract
Onsite
Mid Level
3+ years expGandiv Insights LLC is seeking an HVAC Validation Engineer responsible for IQ/OQ/PQ of HVAC systems supporting pharmaceutical manufacturing, labs, and cleanrooms in compliance with cGMP, FDA, and ISO standards. The role involves performing HVAC validation and coordinating with various teams to ensure compliance and support regulatory audits.
Information Technology & Services
Responsibilities
Perform HVAC IQ/OQ/PQ and cleanroom qualification
Execute temperature, humidity, pressure, and airflow mapping
Conduct HEPA testing and smoke studies
Prepare and execute validation protocols and reports
Support change control and regulatory audits
Coordinate with Engineering, QA, and Facilities teams
Qualification
Required
BS in Mechanical Engineering or related field
3+ years HVAC validation experience in pharma/biotech
Strong knowledge of cGMP, FDA, ISO 14644, EU Annex 1
Experience with BMS/EMS and GMP documentation
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase