Ort: Switzerland - Meyrin/Geneva
Funktion: Quality Management
Firma: OM Pharma
In view of our continued global growth we need to assure that our systems keep up to support our manufacturing unit. For this reason 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.
OM Pharma is a global Geneva-based Biotech company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and continues to invest into R&D to develop microbial derived immunotherapeutic products addressing acute and chronic immunological disorders resulting from infections and inflammation. OM Pharma is operating to highest Good Manufacturing Practice (GMP) standards which rely on a high level of Biotech competencies and experienced teams.
The company strives to help patients around the world to live better lives by allowing access to a better management of infectious diseases and immunological imbalances.
For more information, please visit: ompharma.com.