CSV Engineer In 13 years, the EFOR Group has reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions. Our ambition is to build a global leading position of our market in 2028. Today, we are an innovative organization working with passionate specialists and committed consultants according to our three values: Commitment, Excellence and Sharing. In Switzerland, we work with 300 experts who support our customers on their various projects in the French- and German-speaking parts. We help our customers to diversify and to grow through the work of our consultants and the technical expertise of our Solution & Project Delivery Department. To strengthen our team in Visp we are looking for a CSV Engineer The Role: You will be supporting eQMS Project, from a CSV perspective. You are responsible for ensuring that the regulations regarding Computer System Validation and Data Integrity are implemented and rolled out according to applicable regulations (CFR 21 part 11, GAMP5) and internal standards for a Trackwise eQMS Project. You also support the project team with answers regarding data integrity and the validation of computerized systems. Your Responsibilities: Coordinating the validation activities for eQMS Project Contact person for all project team members regarding questions about CSV and Data Integration (DI) Definition of the strategy of CSV/DI process for the eQMS Project Produce the supporting validation documents (including but not limited to Validation plan, FS, DS, FRA, URS, CS, IQ, OQ and PQ test script protocols, AfiU, VSR) to the eQMS Project Ensuring that the eQMS Project remains in compliance with quality and regulatory requirements according to the applicable standards (GMP) and internal SOPs regarding Computer System Validation and Data Integrity and that processes are carried out in a timely manner Ensure Risk-based validation approaches are applied Edit and review change requests, CAPAs and deviations with regards to CSV and DI related to eQMS Project Define/contribute to CSV&DI guidance influencing strategy Ensure compliance within the eQMS Project Produce all necessary documents to support validation strategy design and execution Your Qualifications & Experience: Expert in CSV Good understanding of GAMP5 and CFR Part 11 requirements Demonstrated Knowledge of Trackwise Spring25 or above – QMS Module At least 5 year’s experience in leveraging CSV documentation and insights in multidisciplinary project teams Strong team-oriented mindset Structured, focused, and well-organized working style Open-minded and receptive to new ideas and suggestions Agile, highly motivated, and driven Solution-oriented with a proactive approach to problem-solving This is an on-site role. Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered. Do you want to join a dynamic and ambitious company? EFOR is made for you. #J-18808-Ljbffr
CSV Engineer Arbeitgeber: EFOR
Als Arbeitgeber in der biopharmazeutischen Branche bieten wir Ihnen die Möglichkeit, in einem dynamischen und innovativen Umfeld zu arbeiten, das auf Teamarbeit und kontinuierliche Verbesserung setzt. Unsere Unternehmenskultur fördert nicht nur die persönliche und berufliche Weiterentwicklung, sondern bietet auch attraktive Benefits wie flexible Arbeitszeiten und ein unterstützendes Arbeitsumfeld. In der Region Rheinland-Pfalz profitieren Sie von einer hervorragenden Lebensqualität und einer starken Gemeinschaft, die Ihre Karriere im Bereich Clean Utilities vorantreibt.
