Deviation Specialist – BioAtrium

About the role

Join the newly formed BioAtrium team in Visp as the dedicated Deviation Specialist. You will lead investigations of deviations in a large‑scale mammalian cell culture facility, ensuring that life‑saving medicines meet the highest safety and quality standards.

Key responsibilities

• Own deviation investigations for the Operations Unit, establishing root causes and assessing product impact.
• Collaborate with Subject Matter Experts and cross‑functional teams to gather technical insights.
• Apply problem‑solving tools such as Fishbone Diagrams, Fault Tree Analysis, and Defense Analysis.
• Define robust CAPAs and conduct Effectiveness Checks to prevent recurrence.
• Author and drive quality records to closure in compliance with cGMP guidelines.
• Support change‑management and continuous‑improvement initiatives to enhance process resilience.

Required profile

• Academic degree (Bachelor or equivalent) in Biotechnology, Chemistry, Life Sciences or related field.
• Hands‑on experience managing deviations and ensuring cGMP compliance in a regulated pharmaceutical or API environment.
• Strong knowledge of biotechnology manufacturing, preferably large‑scale mammalian cell culture.
• Familiarity with Human and Organizational Performance (HOP) principles and risk‑management methodologies.
• Professional fluency in English; German language skills are a plus.
• Structured, focused, and agile working attitude with high motivation to build a new team.

Required skills

• Fishbone Diagrams
• Fault Tree Analysis
• Defense Analysis
• CAPA development and effectiveness checks
• cGMP compliance
• Large‑scale mammalian cell culture processes
• Risk management methodologies

What we offer

• Agile career and dynamic working culture.
• Inclusive and ethical workplace.
• Competitive hourly rate.
• 6‑month contract, 41 hours per week.