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