Description

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.

Requirements

• •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

Tasks

• •Lead Qualification and Validation activities
• •Prepare qualification plans, protocols, and reports
• •Plan and execute equipment and system qualifications
• •Conduct cleaning and process validation with stakeholders
• •Develop and qualify sterilization processes
• •Participate in risk analysis of equipment and systems
• •Plan and execute Computerized Systems Validation (CSV)
• •Support improvement projects for qualification activities
• •Assist in change, deviation, and CAPA management
• •Train new employees on equipment qualification and validation

Tools & Technologies

Benefits