Ort: Switzerland - Meyrin/Geneva
Funktion: Technical Operations
Firma: OM Pharma
In view of our continued global growth we are expanding our production capacities. For this reason we are looking for further support and recruiting our new Validation Engineer at our biotech production site in Meyrin/Geneva. In this position you take care of the manufacturing and cleaning processes validations. Reporting to the Head of Validation & Process Engineering your main missions are as follows:
- Contribute to establish strategies for process and cleaning validations and continuous cleaning and process verification
- Lead risk analyses in close collaboration with Manufacturing, QA, QC and P&ID teams and establish related validation strategies
- Execute validation activities according to planning: process and cleaning validation in the frame of site projects, continuous validations, DHT/CHT validations, manufacturing holding times, validation of manual cleaning processes etc
- Manage and coordinate the corresponding operational activities in close collaboration with Manufacturing, QA, P&ID teams and QC laboratories
- Act as Validation SME/interface for projects of the site: attend to project team meetings and contribute to projects (validation strategies, planning, execution, etc.)
- Write and review validation protocols, raw data, reports and SOP’s of the unit in compliance with GMP
- Define, monitor, implement and close CAPA and change control (risk analysis, action plan, action owner …) in collaboration with the various departments involved.
- Manage deviations issued as part of validation activities
- Site support: answer to questions the field of process and cleaning validations from other departments such as Manufacturing, QA, RA-CMC, QC
- Provide all relevant data to fulfill validation parts of regulatory file
To carry out these tasks the ideal candidate will have an Engineering/Master degree in a closely related area in addition to the following:
- You bring at least 5 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 statistics would be a plus
- Full fluency in French and very good written and oral knowledge of English are 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 like to take a step back to analyze situations and propose new strategies You define yourself as a solution-oriented and methodical person who drives novelty. Thanks to your communication skills and strong team spirit, you integrate quickly into a new environment and easily establish collaborative links with other departments.
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.