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 - 5 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.
As long as the job ad is online, you can apply quickly and easily.
At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.
All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).
When it’s not just a job, but your calling. When you have an impact on people’s lives every day. When you can’t imagine doing something else. Then you know it’s Fresenius.