Process Expert
Process Expert - Visual Inspection
Overview
Join a global pharmaceutical manufacturer operating a modern sterile drug product facility in Switzerland. The site supports end‑to‑end development and commercial production of injectable medicines for customers worldwide. As a Process Expert within the Visual Inspection team, you will play a key role in ensuring products are inspected consistently, safely, and in line with GMP expectations.
Key Responsibilities
- Ensuring all aseptic drug products (vials, lyophilizates, pre‑filled syringes) are reliably inspected using semi‑automatic and fully automated visual inspection systems.
- Providing scientific, statistical, and technical support to project teams on complex process or equipment topics.
- Supporting qualification, validation, and lifecycle management of visual inspection equipment (AVI, SAVI, CCIT).
- Leading troubleshooting activities and driving process improvements to enhance inspection performance.
- Providing hands‑on shopfloor support, working closely with Operators to ensure safe, compliant, and on‑time batch execution.
- Leading deviation and complaint investigations, identifying root causes, and managing actions and CAPAs in TrackWise.
- Maintaining all inspection processes in an audit‑ready state and supporting customer and authority inspections.
- Training team members on new processes, products, and inspection systems.
What Experience You Bring
- Strong experience with semi‑automatic or fully automated visual inspection systems in a GMP‑controlled aseptic production environment.
- Experience with qualification or design documentation under GMP (advantageous).
- Exposure to customer or health authority audits (plus).
- University degree in engineering, life sciences, pharmacy, or similar.
- Fluency in English or German with at least a basic understanding of the other language.
- Proactive, independent working style with confidence in decision‑making and taking ownership.
FAQs
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