ph3Cleaning Validation Expert – Responsibilities /h3 pIn this role, you will be responsible for the cleaning validation related activities in our biopharmaceutical plant and help ensure the highest standards of quality and compliance. /p ul liDevelop and coordinate equipment cleaning validation strategy and activities for the assigned projects in the Large-Scale Mammalian facility of Lonza Visp in collaboration with operations, QA/MSAT cleaning and QC. /li liPrepare, organize and execute project specific cleaning validation related documentation (protocols, reports, annual cleaning review) according to Lonza procedures and in compliance with regulatory. /li liReview and approve cleaning related documents (QC studies, risk assessment, etc.). /li liReview and approve project specific cleaning validation documents (including clean/dirty hold time plan/reports, annual cleaning review of the facility). /li liCoordinate troubleshooting and support investigations of deviations (and approve DR). /li liAct as a Subject Matter Expert (SME) for non-conformity records, technical changes and change requests. /li liBe the main counterpart of cleaning experts. /li liAct as cleaning SME during inspections by healthcare authorities and customer audits. /li /ul h3Key Requirements /h3 ul liMaster’s or PhD degree in biotechnology, life sciences, or related disciplines. /li liSome working experience in biopharma cleaning and/or cleaning validation (preferably in mammalian manufacturing process). /li liWorking experience in cGMP-regulated biopharmaceutical environment and good understanding of the biologics manufacturing process and associated cleaning regulatory requirements. /li liProven experience in managing complex projects, ideally in MSAT or Quality. /li liAbility to manage multiple tasks and meet deadlines effectively. /li liExposure to process development, upstream/downstream processes, scale-up, and/or manufacturing (preferably mammalian cell culture) is an advantage. /li liExperience engaging with regulatory agencies (Swissmedic, FDA, etc.) is an advantage. /li liExcellent communication, technical writing, and stakeholder management skills. /li liFluency in English (written and spoken); German is an advantage. /li liAble to come on site in Visp 80% of the time. /li /ul h3Location /h3 pTN Switzerland · Canton of Lucerne, Switzerland /p /p #J-18808-Ljbffr
