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
* 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 — conception and integration, not only CQV or FAT support
* Direct experience authoring FS / TS and leading Detailed Design phases
* Technical ownership through FAT on aseptic filling lines
* Strong knowledge of cGMP and EU Annex 1 requirements
* Ability to lead technical partners in a complex, multi-project environment
* German B2+ minimum — mandatory (working language on site)
* Professional English required
Strong assets
* Familiarity with containment systems (closed RABS, H₂O₂ isolators)
* Experience on site during greenfield or revamping start-up phases
Languages
Conditions
* Location: Canton of Bern, Switzerland — full on-site presence required
* Contract: Consulting mission
* Experience level: Senior (10+ years)
Fabrice Cattant — Founder, Recrutis | Expert & Executive Search in Life Sciences
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