Senior Qualifizierungsingenieur Pharma-Reinmedien

About the role

The Senior Qualification Engineer is responsible for bringing critical supply systems for pharmaceutical and biotechnological sites into a qualified and inspection-ready state. This includes managing the technical and documentation lifecycle for high-purity water, steam, and process gas systems from planning to final release. The role ensures all systems meet GMP, FDA, and EU regulatory requirements.

Responsibilities

• Planning and managing the commissioning, qualification, and validation of pharmaceutical media supply systems
• Creating, executing, and approving IQ/OQ/PQ protocols and final reports
• Evaluating design documents, specifications, and supplier documentation
• Drafting and reviewing User Requirement Specifications (URS), functional specifications, and risk analyses
• Coordinating between engineering, construction, quality, and operations departments
• Resolving technical issues during commissioning and qualification
• Supporting deviations, root cause analyses, and change controls
• Maintaining audit-ready documentation and representing systems during inspections

Required skills

• GMP
• FDA regulations
• EU-GMP Annexes
• IQ/OQ/PQ
• URS
• Risk analysis
• Technical documentation
• Change control
• Project management

Nice to have

• Large-scale project management
• Computerized system validation
• Supplier management

Qualifications

• Degree in Engineering, Natural Sciences, or a comparable field

Certifications

• ISPE
• ASQ