Location: Switzerland - Meyrin/Geneva
Division: Technical Operations
Company: OM Pharma
Seniority Level: Specialist
In view of our continued global growth we are expanding our production capacities. For this reason we are looking for further support and are recruiting our new Validation Engineer in Meyrin/Geneva. In this position you take care of the manufacturing process, cleaning and transport validations. Reporting to the Head of Validation & Process Engineering your main missions are as follows:
- Execute validation activities according to planning: process and cleaning validation in the frame of site projects, continuous cleaning validation, DHT/CHT validations, manufacturing holding times, validation of manual cleaning processes etc
- Write and review validation protocols, raw data, reports and SOP’s of the unit in compliance with GMP
- Attend to project team meetings and contribute to projects as validation SME: validation strategies, planning, execution
- Carry out criticality analyzes and risk analyzes on components and processes
- Establish related validation strategies
- Review qualification and validation files
- Follow up on deviations, as well as change controls and CAPA related to validation activities
- Site support: answer to questions from other departments such as Manufacturing, QA, RA-CMC, QC
- Actively participate in projects, in particular for the validation of new manufacturing processes.
To carry out these tasks the ideal candidate will have an Engineering/Master degree in addition to the following:
- You bring at least 3 years of experience to a similar position in a pharmaceutical or biotechnology industry
- You have a good knowledge and experience in GMP
- You are fully at ease with the usual IT tools
- Experience in risk analysis and statistics would be a plus
- Full fluency in French. Very good written and oral knowledge of English is a must
You are a rigorous person and autonomous in your work. Endowed with an entrepreneurial spirit, you know how to manage different cross functional stakeholders. You define yourself as a solution-oriented and methodical person who drives novelty.
If this sounds like you please do apply to this new position with us at OM Pharma 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.