Key activities & responsibilities

• Leading assigned Qualification and Validation activities
• Preparation of qualification plans, protocols, reports and procedures based on internal and external rules and standards
• Planning and execution of equipment and system qualifications as well as cleaning and process validation in cooperation with equipment/process owners (IPTs), contractors, and suppliers
• Perform/participate cycle development, qualification and re-qualification of sterilization processes (thermal, chemical, other physical methods)
• Participation and moderation of risk analysis of equipment, systems, and processes
• Planning and execution of Computerized Systems Validation (CSV) in corporation with IT and Process Automation
• Supporting improvement projects and problem solving for qualification and validation activities
• Support for change, deviation, and CAPA management
• Responsible for being compliant with safety guidelines and being capable of recognizing unsafe situations and acting safely on the job

Qualification

• Degree in Biotechnology, Process Engineering, Biochemistry, Microbiology, or similar disciplines
• Valdiation and qualificational background (min 3-5 years)
• Technological understanding for blend processes
• Experience in pharmaceutical environment with GMP-requirements
• Knowledge in qualification (IQ and OQ)
• Experienced working in an interdisciplinariy project team
• Excellent English skills and basic German skills
• Practical knowledge in Ellab equipment handling (would be a plus)
• Knowledge of Execute SIP PQ activities (would be a plus)
• Willingness to travel occasionally

We offer

• Full-time position 38h
• Home Office days agreeable
• The chance to work for an international group

 
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