CQV Lead - Stein
Supporting assigned project in Stein as CQV Lead of Filling Lines:
· Interaction with Site Operation / Site QA / SGIE-Quality
· Leading the assigned Team of Drug Product (DP) Ancillary Equipment and Lab Equipment
· Monitor day-to-day Validation activities in accordance with approved SOPs / Plan / Policies
· Participate in review and approval of Validation Protocols / Reports including site discrepancies and deviations investigation / closure
· Support / participate in validation activities during facility startup
· Provide leadership of CQV activities in assigned Project(s) in Switzerland (together with Site Operation, Site QA, SGIE-Quality):
· Responsible for ensuring that CAPEX projects are compliant with the global CQV guidelines, aligned with local procedures and detect/resolve potential gaps in line with Lonza's continuous improvement vision.
· Acting as subject matter expert (SME) on Lonza CQV standards
· Keeping oversight on Lonza CQV -standards, -timelines (etc.)
· Address immediate time/quality constraints and act adequately
· Force RFT thinking and approach
· Considering EHS Requirements
· Involved and support PM and Process Engineers in CQV-Planning:
· Development and delivery of CQV Documents
· Commissioning Documents (Suppliers / Process Engineers/EMR)
· QV-Documents (Suppliers / QV-Team /QA)
· Education: Technical degree (Bachelor's or Master's) in engineering or applied science, post graduate qualification preferred.
· Minimum of 12 years in Commissioning, Qualification and Validation incl. CSV with strong experience in management of complex pharmaceutical projects. Familiarity with biologics as well as chemical manufacturing technologies desirable.
· Significant experience in qualification of aseptic filling lines and associated equipment such as vial washers, depyrogenation tunnels, filling machines, lyophilizers, cappers and isolators
· Significant experience in regulated pharmaceutical industry and/or engineering company with proven experience on planning CQV activities, leading large senior reports and high understanding/management of KPIs.
· Fluent English is a must, Fluent in German strongly beneficial