Validation Engineer - Geneva
Meyrin, Geneva, CH
We are looking for a Validation Engineer to join our headquarters and production site in Geneva. Reporting to the Validation Team Leader and working within a team of five, your mission is to manage all products validations activities, such as cleaning, manufacturing process and transport validation, across technical projects, lifecycle management and compliance initiatives.
Your main responsibilities are as follows :
- Define and execute validation strategies ensuring full compliance with GMP requirements
- Write and review validation documentation: validation plan, risk analysis, protocols and reports
- Plan, coordinate and perform operational validation activities in close collaboration with Manufacturing, QA, QC, Qualification and MSAT teams (including on-site sampling, data collection, and analysis)
- Manage deviations arising from validation activities and contribute to deviation investigations
- Lead or support the implementation of CAPAs and Change Controls in partnership with cross-functional teams
- Contribute to URS establishment to define specific process and cleaning requirements
- Author and review technical sections of CTD submissions
- Write and update SOPs in line with regulatory requirements
- Maintain and update the Validation Master Plan
- Act as the primary validation contact for internal stakeholders and a key representative during Health Authority inspections and partner audits
- Act as project manager for validation project
To carry out this mission, we are looking for a person with the following profile :
- Engineer's degree in Pharmaceutical Sciences, Biotechnology, Chemistry, Food Science, Pharmacy, or a related field
- At least 4 years’ experience in validation within the Pharmaceutical or Biotech industry, including strategy definition and execution
- Strong knowledge of GMP regulations and validation best practices and methodologies
- Fluent in French with very good English (written and spoken)
You are hands-on, rigorous, and solution-oriented, with strong analytical and organizational skills. Your leadership and communication abilities enable you to work effectively across departments and build constructive, collaborative relationships. You also know how to take a step back to challenge existing processes and propose creative and continuous improvements.
If you are looking for a dynamic environment where your ideas matter — apply now and join our team !
About Us
OM Pharma is a global Geneva-based biopharmaceutical 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 invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.
The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.
For more information, visit the website: ompharma.com.
