CSV Engineer

vor 4 Wochen

Schaffhausen, Schweiz Cpl Life Sciences Vollzeit

Senior Consultant @ Cpl Life Sciences - Contract Engineering UK/EU Cpl Life Sciences are looking for a CSV Engineer to support the lifecycle management of computerized manufacturing systems at a pharmaceutical site in Schaffhausen. This is a 1-year contract with hybrid working flexibility. Key Responsibilities Ensure GMP and regulatory compliance for qualification activities of production systems. Review and approve qualification lifecycle documents (e.g., URS, Impact & Risk Assessments, interface qualifications, Audit Trail reviews). Review and approve procedures related to data integrity and lifecycle management of production systems. Support cross-functional teams (Production, IT, Quality) to maintain compliant and reliable manufacturing systems. Investigate and assess data integrity issues and software non-conformities, ensuring compliance with GMP standards. Work with digital qualification tools (e.g., KNEAT) and manufacturing systems (MES, SCADA, OSI-PI, SAP, TrackWise, TruVault). Qualifications & Skills M.Sc. in Natural Sciences, Computer Science, Engineering, or equivalent; or Bachelor’s with relevant GMP experience. Proven experience in GMP-regulated environments and CSV approach (ISPE standard). Strong analytical and problem-solving skills. Fluent in German, with basic English (B1) desirable. Experience with manufacturing systems qualification and data integrity is advantageous. If interested, please apply to the job advertisement or email megan.smyth@cpl.com for further information. Seniority level Mid-Senior level Employment type Contract Job function Pharmaceutical Manufacturing #J-18808-Ljbffr

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