Tasks

- Ensures that an end-to-end microbial control concept is developed for the biotechnological drug substance manufacturing facilities and is captured in local documents (incl. specifications, SOPs, etc.)

- Supports the Quality Oversight on the activities of the Environmental Monitoring and activities related to the assessment of disinfectants from microbiological expertise point of view

- Writes, Reviews and approves SOPs, deviation reports and change requests associated with the above-mentioned topics

- Supports the preparation and follow-up of customer audits and regulatory inspections; acts as an expert during audits / inspections presenting aspects related to the microbial control and sterility strategies

- Enhances the quality knowledge by following the quality standards and by visiting specific training courses/conferences

Qualifications

- University degree (Bachelor, Master or PhD) in pharmacy, engineering, chemistry, or related life sciences discipline, preferably microbiology

- More than 5 years (more than 10 years preferred) of experience in the area of biopharmaceutical manufacturing

- Strong background in cGMPs

- Broad knowledge related to hygiene topics, environmental monitoring, disinfectant testing, microbial control strategies

- Good communication skills and interaction with all kind of interfaces within the organization and with regulatory agencies (e.g. US FDA, EMA, etc.).