Location: Switzerland - Meyrin/Geneva
Division: Technical Operations
Company: OM Pharma
In view of our continued global growth especially in the US Market, we are working on FDA site readiness. For this reason we are looking for further support and recruiting a Validation Engineer at our biotech production site in Meyrin/Geneva. In this position you take care within the project called “FDA Site Readiness” of the activities related to the fields of validation and risk management. Reporting to the Head of Validation & Process Engineering your main missions are as follows:
• Perform or finalize gaps assessment and compliance check in the field of Manufacturing and Cleaning Process Validations
• Establish in close collaboration with the Head of Validation and Process Engineering the corresponding remediation plans
• Establish strategies for process and cleaning validations and continuous cleaning and process verification
• Execute validation activities according to remediation plan: process and cleaning validation including for manual cleanings, periodical validations, DHT/CHT validations, …
• Write 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
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 3 years of experience in validation in pharmaceutical or biotechnology industries
• Experience in GMP manufacturing site
• Very good interpersonal skills with excellent listening and communication skills.
• Full fluency in French and very good written 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, entrepreneurship and strong team spirit, you integrate quickly into a new environment and easily establish collaborative links with other departments.