Senior Qualifying Specialist (1550)

Main responsibilities:

• Develop and maintain commissioning and qualification documents for new plants, including PQs for critical systems and ongoing SLC support post-implementation.
• Supervise and resolve deviations, manage changes (GEP and GMP), and implement CAPAs effectively.
• Coordinate efforts between internal teams and external service providers and suppliers to ensure seamless project execution.
• Present qualification documents during audits and inspections, showcasing the outstanding standards maintained

Your profile:

• Graduate from a technical school (HF) / university of applied sciences (FH) or hold a university degree.
• Proven experience in a regulated GMP environment, specifically in commissioning, qualification, and validation of systems like refrigerators, freezers, clean media, and process engineering equipment.
• Strong proficiency in MS Office; familiarity with COMOS, DMS, Kneat, TrackWise, and SAP is advantageous.
• Proficient in both written and spoken German and/or English.
• Demonstrate independent, flexible work habits, with excellent communication skills and a structured, focused approach to tasks.
• Open to new ideas, agile in thinking, and proactive in problem-solving.