Validation and Qualification Engineer(m/w/x)

In this role, you will lead qualification and validation efforts, ensuring compliance with safety guidelines while collaborating with various teams. Your day-to-day responsibilities will include preparing plans, executing validations, and training new employees.

Anforderungen

• •Bachelor, Master or Engineering degree in Biotechnology, Process Engineering, (bio)chemistry, (micro)biology, or similar disciplines
• •Ability to track qualification/requalification activities
• •Adequate verbal and written communication at all levels of the organization
• •Experience in a GMP production company
• •Experience in equipment qualification and process validation
• •Strong knowledge and hands-on experience of (bio) process technology, microbiology, aseptic processing, and equipment design
• •Practical experience in the application of risk management tools
• •Excellent communication and organizational capacity
• •Experience in change management and ability to manage deviations, CAPAs, etc.
• •Experience in the use of continuous improvement tools and methodologies
• •Very good knowledge of MS-Office applications
• •Very good knowledge of German and English (verbal and written)
• •Accountability, Adaptability, cGMP Compliance, Change Management, Chemical Technology, Column Chromatography, Computer Literacy, Data Analysis, Environmental Health and Safety (EHS) Management, Equipment Set Up, Ethylene Oxide Sterilizers, Executive Communications, GMP Compliance, Immunochemistry, Improvement Projects, IT Operation, Leadership, Lean Manufacturing Tools, Microbiological Cultures, Microbiology, Operations Management, Oral Communications, Process Monitoring, Process Optimization