Senior Qualifizierungsingenieur Downstream Processing

About the role

The Senior Qualification Engineer for Downstream Processing ensures that biopharmaceutical purification processes and equipment 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 coordinating between process development, engineering, construction, quality assurance, and production teams.

Responsibilities

• Plan and lead the commissioning, qualification, and validation of downstream equipment such as chromatography, filtration, and virus inactivation systems.
• Create, execute, and approve IQ/OQ/PQ protocols and final reports.
• Qualify supporting systems including CIP/SIP and single-use technologies.
• Evaluate design documents, specifications, and supplier documentation.
• Prepare and review user requirement specifications (URS), functional specifications, and risk analyses.
• Resolve technical issues during commissioning and qualification and support deviation management and change controls.
• Maintain audit-ready documentation and represent equipment during inspections.

Required skills

• Process Engineering
• Downstream Processing
• GMP
• FDA compliance
• IQ/OQ/PQ
• Technical documentation
• Risk analysis
• Project management

Nice to have

• Large-scale project management
• CSV validation
• Automation systems
• Process control systems
• Supplier management

Qualifications

• Degree in Engineering, Natural Sciences, Bioprocess Engineering, Biotechnology, or a related field
• 8+ years of practical qualification experience in downstream processing in pharma or biotech

Certifications

• ISPE
• ASQ