Senior Qualifizierungsingenieur HVAC & Equipment

About the role

The Senior Qualification Engineer is responsible for ensuring that HVAC and technical systems at pharmaceutical or biotechnological sites are in a qualified and inspection-ready state. You will manage the technical and documentation lifecycle from planning to final release, ensuring compliance with GMP, FDA, and EU requirements. The role involves leading commissioning, qualification, and validation activities for cleanroom ventilation and production equipment.

Responsibilities

• Plan and lead commissioning, qualification, and validation of cleanroom ventilation systems and production/lab equipment.
• Create, execute, and approve IQ/OQ/PQ protocols and final reports.
• Conduct and evaluate cleanroom classifications, filter integrity tests, and environmental mappings.
• Evaluate design documents, specifications, and supplier documentation.
• Create and review user requirement specifications (URS), functional specifications, and risk analyses.
• Coordinate between engineering, construction, quality, and operations departments.
• Resolve technical issues during commissioning and support deviation management and change controls.
• Maintain audit-ready documentation and represent systems during inspections.

Required skills

• HVAC
• GMP
• FDA
• ISO 14644
• IQ/OQ/PQ
• Risk Analysis
• Project Management
• Cleanroom Technology

Nice to have

• Building Management Systems
• Environmental Monitoring
• Supplier Management
• CSV

Qualifications

• Degree in Engineering (Supply, Process, or Mechanical) or Natural Sciences
• Equivalent practical experience

Certifications

• ISPE
• ASQ

About the Company

NXT Hero GmbH is a company operating in the pharmaceutical and biotechnological sector.