Process Engineer

ARTO has partnered with a growing Pharma/Biotech business based in Basel who are seeking 2-3 Process Engineers to support the site build out.

The core mission is to write and finalize process documentation and protocols for isolator-based filling operations (vials and syringes), and ensuring alignment with Swiss medic expectations.

• Write clear, GMP-compliant process protocols and work instructions for:
• Isolator operation and glove use (e.g. 30+ glove positions, glove testing, plate exchange inside isolators).
• Aseptic interventions and material handling in the isolator.
• Filling operations for vials and syringes (fill-finish).
• Smoke study execution and related process descriptions.

• Bring proven aseptic manufacturing / fill-finish experience
• Challenge and refine process concepts.
• Ensure flows, interventions and routines are realistic and inspection-ready.
• Balance “enough detail” vs “overwriting” - no bachelor thesis, but no gaps.

• Draft and review deviations and CAPAs related to process and documentation.
• Ensure documentation reflects Swiss medic / EU GMP expectations for an aseptic fill-finish facility.
• Help the team understand the appropriate GMP level (not under- or over-documenting).

• ~5-12 years in pharmaceutical/biotech aseptic fill-finish (vials/syringes) as a Process Engineer or similar.

• Isolator-based operations.
• Writing process protocols, URS/specifications, and SOP-like technical documents.
• Supporting IQ/OQ and transitioning into PQ and routine manufacturing.
• Prior work with Swiss or EU regulatory environments;
  Swiss medic exposure is a plus.