Canton of Bern · On-site · Consulting mission · Senior level (10+ years) · German B2+ required · English required* Assignment via a specialist pharma/biotech consulting firm — GXP Consulting Switzerland. Full administrative support and mission follow-up included.* *Context**
As 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 Responsibilities** Design & Engineering* Lead Basic Design and Detailed Design phases — author and validate Functional Specifications (FS) and Technical Specifications (TS) Coordinate engineering partners and equipment vendors on technical deliverables Validate aseptic process concepts and RABS / isolator integration (Grade A – ISO 5) Oversee automation, utilities, and layout interfaces Fill & Finish – Aseptic Manufacturing* Hands-on expertise on liquid and/or lyophilized filling lines Design and integration of RABS / isolators in sterile environments Technical ownership through FAT phases at vendor sites and on-site Project Interface* Close collaboration with Engineering, Automation, CQV and Production teams FAT support and commissioning preparation Ensure design solutions comply with GMP requirements and EU Annex 1 *Your Profile**
Required
10+ years of experience in aseptic Fill & Finish within pharma / biotech Confirmed expertise in RABS and/or isolator design — con