Ort: Switzerland - Meyrin/Geneva
Funktion: Research and Development
Firma: OM Pharma
In view of our continued global growth, we are creating new job opportunities and recruiting a Validation Engineer for our biotech production site in Geneva. In this position, you report to the Head of Validation and you manage the Cleaning and Manufacturing Process validation activities, mainly for routine validations (periodical cleaning validation, products LCM, validation compliance …) and also for some technical projects. Your main responsibilities are the following:
- Establish validation strategies with the support of relevant departments with a focus on routine validation (periodical cleaning verification and products LCM) ensuring compliance to GMP
- Manage and supervise the daily activities of one Validation Technician
- Write and review validation protocols, test sheets and reports
- Lead risk analyses
- Coordinate, schedule and execute operational validation activities in close collaboration with Manufacturing, QA, QC, Technical Engineering and Development teams: validation sampling on manufacturing area, provide samples to QC, data collection and results analysis
- Manage deviations issued as part of validation activities
- Provide specific process and cleaning validation requirements for the establishment of new equipment URS
- Promote operational excellence in validation activities
- Ensure a regulatory watch on the validation requirements in the pharmaceutical field and adapt SOPs / systems if needed
To successfully perform those missions, you bring the following profile:
- Engineering or Master degree in Pharmacology, Biotechnology, Food industry, or related areas
- At least 5 years of experience in validation in pharmaceutical or biotechnology industries, with a strong expertise in cleaning process validation
- Excellent knowledge of GMP
- Very good interpersonal and communications skills
- Full fluency in French with very good command in English, both in oral and written conversation
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, entrepreneurship and team spirit, you integrate quickly into a new environment and easily establish collaborative links with other departments.
If you are looking for a company where you can develop new ideas and leave your footprint, join OM Pharma!
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.