Canton of Bern · On-site · Consulting mission · Senior level (10+ years) · German B2+ required · English requiredAssignment via a specialist pharma/biotech consulting firm — GXP Consulting Switzerland. Full administrative support and mission follow-up included.ContextAs part of a strategic programme at a leading international biopharmaceutical company in Switzerland, Recrutis is recruiting on behalf of GXP Consulting Switzerland an experienced Design Engineer Lead – Fill & Finish to take technical ownership of multiple aseptic filling lines.The role spans the full design cycle — from Basic Design through FAT — with direct responsibility for engineering deliverables and project interfaces. This is not a CQV role, nor a Project Manager position: it requires confirmed technical lead expertise in aseptic line design, with hands-on knowledge of RABS and isolator technologies.Key ResponsibilitiesLead Basic Design and Detailed Design phases — author and validate Functional Specifications (FS) and Technical Specifications (TS)Coordinate engineering partners and equipment vendors on technical deliverablesValidate aseptic process concepts and RABS / isolator integration (Grade A – ISO 5)Oversee automation, utilities, and layout interfacesFill & Finish – Aseptic ManufacturingHands-on expertise on liquid and/or lyophilized filling linesDesign and integration of RABS / isolators in sterile environmentsTechnical ownership through FAT phases at vendor sites and on-siteProject InterfaceClose collaboration with Engineering, Automation, CQV and Production teamsFAT support and commissioning preparationEnsure design solutions comply with GMP requirements and EU Annex 1Your ProfileRequired:10+ years of experience in aseptic Fill & Finish within pharma / biotechConfirmed expertise in RABS and/or isolator design — conception and integration, not only CQV or FAT supportDirect experience authoring FS / TS and leading Detailed Design phasesTechnical ownership through FAT on aseptic filling linesStrong knowledge of cGMP and EU Annex 1 requirementsAbility to lead technical partners in a complex, multi-project environmentGerman B2+ minimum — mandatory (working language on site)Professional English requiredStrong assetsFamiliarity with containment systems (closed RABS, H₂O₂ isolators)Experience on site during greenfield or revamping start-up phasesLanguagesConditionsLocation: Canton of Bern, Switzerland — full on-site presence requiredContract: Consulting missionExperience level: Senior (10+ years)Fabrice Cattant — Founder, Recrutis | Expert & Executive Search in Life Sciences
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