We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations. Around the world, all of us are committed to our shared endeavor: caring for life.
#careerswithapurpose at Fresenius
Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
- Development, improvement and implementation of technical Standards for process control strategies for GMP regulated sterile production environments,
- Support of production sites in establishing risk-based control strategies for manufacturing and support processes
- Compliance assessments of process control strategies within company's production network, assessment of GMP compliance of equipment, utilities and facilities
- Technical support and internal consulting in engineering projects for new and renovated equipment, utilities, and facilities
- Analysis of manufacturing processes regarding process improvements and support in implementing process improvements and controls
- Support in implementing modern, digital quality concepts in production environments
- Preparation of and response to authority inspections
- Design and evaluation of qualification and validation strategies and support in qualification / validation projects
- Internal consulting regarding technical GMP requirements
- Review and check of technical documentation
- University degree in relevant engineering disciplines or equivalent
- Min. 3 years of vocational experience in sterile manufacturing environments or in engineering and design of sterile manufacturing processes / facilities
- Relevant vocational experience on international level, work within or leadership of international teams and intercultural skills
- Excellent knowledge of technical norms / standards, international GMP-requirements and guidelines (ISPE, PDA etc.)
- Experience in sterile pharmaceutical production process and the respective regulatory requirements
- Experience in applying quality tools and methods
- Experience in qualification of equipment, utilities and facilities and process validation
- Knowledge of statistical tools
- Willingness to travel (internationally)
- Fluent in English, further language skills are advantageous
- IT knowledge: MS Office, Visio, technical applications, CAD, Minitab etc.
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