h3CSV Engineer /h3 pIn 13 years, the bEFOR Group /bhas reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions. /p pOur ambition is to build a global leading position of our market in 2028. /p pToday, we are an innovative organization working with passionate specialists and committed consultants according to our three values: bCommitment, Excellence and Sharing. /b /p pIn 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 bSolution Project Delivery Department. /b /p pTo strengthen our team in bVisp /b we are looking for a bCSV Engineer /b /p h3The Role: /h3 pYou will be supporting eQMS Project, from a CSV perspective. /p pYou 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. /p pYou also support the project team with answers regarding data integrity and the validation of computerized systems. /p h3Your Responsibilities: /h3 ul liCoordinating the validation activities for eQMS Project /li liContact person for all project team members regarding questions about CSV and Data Integration (DI) /li liDefinition of the strategy of CSV/DI process for the eQMS Project /li liProduce 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 /li liEnsuring 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 /li liEnsure Risk-based validation approaches are applied /li liEdit and review change requests, CAPAs and deviations with regards to CSV and DI related to eQMS Project /li liDefine/contribute to CSVDI guidance influencing strategy /li liEnsure compliance within the eQMS Project /li liProduce all necessary documents to support validation strategy design and execution /li /ul h3Your Qualifications Experience: /h3 ul liExpert in CSV /li liGood understanding of GAMP5 and CFR Part 11 requirements /li liDemonstrated Knowledge of Trackwise Spring25 or above – QMS Module /li liAt least 5 year’s experience in leveraging CSV documentation and insights in multidisciplinary project teams /li liStrong team-oriented mindset /li liStructured, focused, and well-organized working style /li liOpen-minded and receptive to new ideas and suggestions /li liAgile, highly motivated, and driven /li liSolution-oriented with a proactive approach to problem-solving /li /ul pbThis is an on-site role. /b /p pbOnly applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered. /b /p pbDo you want to join a dynamic and ambitious company? EFOR is made for you. /b /p #J-18808-Ljbffr
CSV Engineer in Raron 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.
