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Csv manager - geneva

Meyrin
OM Pharma
Inserat online seit: 11 März
Beschreibung

Following an internal career move, we are recruiting a Computerized System Validation Manager based at our headquarters and biotech production site in Meyrin. Reporting to the Head of Qualification & Validation and joining a team of two, your mission is to safeguard the integrity and compliance of our computerized systems, ensuring they effectively support operational excellence, regulatory readiness and long-term performance.Your Main Responsibilities Are As FollowsAct as the main point of contact for all CSV and Data Integrity topics related to laboratory equipment, manufacturing systems and IT systemsDefine, implement and continuously improve CSV and Data Integrity strategies for projects (new equipment, upgrades, improvements) and routine activitiesEnsure GMP-compliant validation lifecycle management of systems under your responsibilitySupport investigations, deviations, and CAPAs related to computerized systemsLead CSV-related inspection and audit preparation, acting as subject matter expert during regulatory inspectionsDrive continuous improvement initiatives to strengthen system robustness and data integrity cultureTo carry out this mission, we are looking for a person with the following profile:Bachelor’s or Master’s degree in Engineering, Computer Science, Automation, Industrial Systems or related fieldMinimum 5 years of experience in Computerized System Validation within the pharmaceutical or biotech industryStrong knowledge of pharmaceutical requirements and guidelines (GMP – Annex 11, GAMP 5)Good understanding of industrial automation systems (SCADA, PLC, recipe management systems)Native or fluent French speaker with strong professional proficiency in English (written and oral)You are a proactive and solution-oriented professional who thrives in a fast-paced, collaborative and hands-on environment. Pragmatic by nature, you know how to balance efficiency with the quality and compliance standards. With excellent communication and interpersonal skills, you build strong relationships across IT, Engineering, QA, and Operations. Analytical and structured, you assess risks and define robust, practical validation strategies, combining methodological rigor with a continuous improvement mindset.Join OM Pharma and help us advance our mission to improve patients’ lives—apply today and make a real impact!About UsOM 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 .
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