Senior Deviation Specialist

Senior Deviation Specialist

Lonza

Visp, Switzerland

The Senior Deviation Specialist will be part of a team that is currently established to own and investigate deviations at our Bioconjugates facilities in MC1 and PCP.

The Senior Deviation Specialist represents the Operations Unit, taking ownership of Deviations which arise; to investigate the root cause(s), the (potential) impact on product and/or systems, and to define appropriate CAPA(s) as solutions.

What you will do:

• Responsible to own, investigate, author, and record assigned Deviations.
• Liaise with Subject Matter Experts (SMEs) and key stakeholders to establish the root cause(s) of deviations and the potential impact of said deviations.
• Ensure accurate investigation tools are used to systematically define all root causes and contributing factors (e.g. Logic Fault Tree, Defense analysis, Event & Causal Factors chart, Fishbone)!
• Define and agree with SMEs appropriate CAPA(s), and associated Effectiveness Checks.
• Ensure cGMP compliance and consistency through the investigation process and drive their quality records to completion and closure according to scheduled release times.
• Support the business through ongoing change and process improvement activities.

What we are looking for:

• PhD, Master or Bachelor degree or equivalent experiences in chemistry, biotechnology, life science or related field.
• Solid experience in Deviations and cGMP in a regulated pharmaceutical or biotech industry.
• Knowledge of bioconjugation manufacturing processes and analytical methods.
• Technical writing & presentation/communication skills are key for the role.
• Experience with Human and Organizational Performance & risk management approaches is an advantage with the ability to work with and manage a team of SMEs without formal authority as well as to deliver full projects working independently.
• Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
• Fluent in English and German highly desirable.