The role:
The Associate III within the Integrated Downstream Quality Operations team is being part of the Quality Department at the new Large-Scale Manufacturing facility located at the Solothurn/Switzerland site. He/She focuses on Quality Operations and Quality Engineering activities for downstream manufacturing and equipment. The Solothurn site is intended to operate with a fully integrated electronic batch record for all commercial, clinical and PPQ campaigns.

General Information:
Start Date: 01.11.2026
End Date: 31.03.2027 (extension planned)

Department: Quality Assurance, Integrated Downstream Quality Operations

Responsibilities:

• Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure the safety, efficacy and purity of the products manufactured by Biogen
• Reviews and approves GMP Engineering and Manufacturing documents during both project and operational phases of the site, specifically related to procedures, work instructions, CAPAs, deviations, change control, equipment (work orders, P&IDs, qualification protocols, calibration deviations..,) etc.
• Partners with Manufacturing, Manufacturing Sciences, Process Engineering, Automation SMEs during deviation management and investigations.
• Take part to the monitoring and release activities for Column Packing / Unpacking and Chromatography Review.
• Ensures adherence to internal procedures during downstream manufacturing operations or for equipment controls and release before and during GMP CAPEX and OPEX project (i.e., shutdowns, construction projects) or New product introduction
• Take part of the Quality On-Call duty rotation for Quality
• Participates in batch record review and close out in the view of batch release.
• Experience with Quality Assurance, Equipment Qualification, Downstream Process is preferred.
• Demonstrated ability to work autonomously with cross-functional team members.
• Strong presentation and organizational skills
• Demonstrated writing skills
• Demonstrated problem solving skills
• English B1 as a minimum.

If you are interested, please apply with a copy of your CV.