PpARTO has partnered with a growing Pharma/Biotech business based in Basel who are seeking 2-3 Process Engineers to support the site build out. /ph3Mission / Purpose /h3pThe core mission is to write and finalize process documentation and protocols for isolator-based filling operations (vials and syringes), and ensuring alignment with Swissmedic expectations. /ph3Key Responsibilities /h3h3Protocol Specification Authoring /h3ulliWrite clear, GMP-compliant process protocols and work instructions for: /liliIsolator operation and glove use (e.g. 30+ glove positions, glove testing, plate exchange inside isolators). /liliAseptic interventions and material handling in the isolator. /liliFilling operations for vials and syringes (fill-finish). /liliSmoke study execution and related process descriptions. /li /ulh3Aseptic Process Expertise /h3ulliBring proven aseptic manufacturing / fill-finish experience /liliChallenge and refine process concepts. /liliEnsure flows, interventions and routines are realistic and inspection-ready. /liliBalance “enough detail” vs “overwriting” - no bachelor thesis, but no gaps. /li /ulh3Deviations, CAPAs GMP Writing /h3ulliDraft and review deviations and CAPAs related to process and documentation. /liliEnsure documentation reflects Swissmedic / EU GMP expectations for an aseptic fill-finish facility. /liliHelp the team understand the appropriate GMP level (not under- or over-documenting). /li /ulh3Experience /h3ulli~5-12 years in pharmaceutical/biotech aseptic fill-finish (vials/syringes) as a Process Engineer or similar. /li /ulh3Hands-on experience in: /h3ulliIsolator-based operations. /liliWriting process protocols, URS/specifications, and SOP-like technical documents. /liliSupporting IQ/OQ and transitioning into PQ and routine manufacturing. /liliPrior work with Swiss or EU regulatory environments; Swissmedic exposure is a plus. /li /ul /p #J-18808-Ljbffr