Your assignments
1. Development, improvement, and implementation of technical Standards for process control strategies for GMP regulated sterile production environments,
2. Support of production sites in establishing risk-based control strategies for manufacturing and support processes
3. Compliance assessments of process control strategies within company’s production network, assessment of GMP compliance of equipment, utilities and facilities
4. Technical support and internal consulting in engineering projects for new and renovated equipment, utilities, and facilities
5. Analysis of manufacturing processes regarding process improvements and support in implementing process improvements and controls
6. Support in implementing modern, digital quality concepts in production environments
7. Preparation of and response to authority inspections
8. Design and evaluation of qualification and validation strategies and support in qualification / validation projects
9. Internal consulting regarding technical GMP requirements
10. Review and check of technical documentation
Your profile
11. University degree in relevant engineering disciplines or equivalent
12. Min. 3 - 5 years of vocational experience in sterile manufacturing environments or in engineering and design of sterile manufacturing processes / facilities
13. Relevant vocational experience on international level, work within or leadership of international teams and intercultural skills
14. Excellent knowledge of technical norms / standards, international GMP-requirements and guidelines (ISPE, PDA etc.)
15. Experience in sterile pharmaceutical production process and the respective regulatory requirements
16. Experience in applying quality tools and methods
17. Experience in qualification of equipment, utilities and facilities and process validation
18. Knowledge of statistical tools
19. Willingness to travel (internationally)
20. Fluent in English, further language skills are advantageous
21. IT knowledge: MS Office, Visio, technical applications, CAD, Minitab etc.