We are looking for further support and recruiting our new Computerized Systems Engineer in Meyrin/Geneva. In this position you take care of our production systems, data integrity and automation systems.
Reporting to the Head of Computerized Systems your main missions are as follows:
- Take charge of CSV activities (assess equipment, understand level of qualification needed, write risk assessments, write validation plan etc.)
- Manage and administrate the IT-systems for laboratory and manufacturing - 1st and 2nd -level support for users
- Be a specialist on data integrity for the systems in your scope
- Make sure software and SOP updates are done regularly
- Ensure the technical support for user services on any improvement concerning GMP compliance and for investigations
- Definition and implementation of qualification strategies, to guarantee reliability and conformity to GMP of production and laboratory infrastructure, including related documentation
- Support on inspections of the systems with regards to GMP aspects
- Project delivery in accordance with TOP-Team and Capex decisions
- Alignment of CAPAs and Deviation KPIs as well as OE plan KPIs
The ideal candidate will have a degree in Engineering in addition to the following:
- Several years of experience in CSV in an industry setting (ideally manufacturing in Pharma)
- Thorough knowledge of data integrity rules and guidelines (CFR 21 part 11, Annex 11 European GMP, GAMP 5)
- Automation knowledge
- Technical knowledge on iFix, Wonderware, Winprogress, WinCC would be an advantage
- Fluency in French and good knowledge in English are a must
You are a rigorous person and autonomous in your work. You know how to manage different cross functional stakeholders and feel very comfortable to communicate with them efficiently. While having a critical and innovative attitude you follow a lean and pragmatic approach.
If this sounds like you please do apply to this new position with us at OM Pharma in our headquarter in Meyrin/Geneva.