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Pharmacist as Validation Manager (m / f / d)

Pharmacist as Validation Manager (m / f / d)

BioNTech SEMainz, Rheinland-Pfalz, Germany
Vor 2 Tagen
Stellenbeschreibung

Manager

  • Validation MS&T

Mainz, Germany | full time | Job ID : 8958

At the iNeST facility, cancer therapeutics will be produced individually for each patient in order to meet their personal needs. The Pilot Facility is designed for high-throughput production.

Your main responsibilities are :

  • Creation and maintenance of the validation concept for the Pilot Facility
  • Planning of validation activities for the establishment of new products and optimization of existing processes, including the creation of validation reports
  • Technical leadership in validation activities (process validation, cleaning validation, etc.)
  • Responsible for training the operational departments on the validation activities
  • Creation and maintenance of process-relevant documents (process risk analyses, process descriptions, etc.)
  • What you have to offer :

  • Degree in Pharmacy, Biotechnology, Natural Sciences, or Engineering
  • 4-5 years of relevant experience in a regulated GMP environment
  • Professional experience in process validations of biotech products
  • Solid knowledge of US and EU regulations and experience in dealing with respective authorities
  • Excellent communication and organizational skills
  • Detail-oriented, excellent problem-solving skills, and critical thinking abilities
  • Fluent in German and English
  • Please note that this position is a limited replacement for parental leave. Your Benefits : It's our priority to support you :

  • Your flexibility : flexible hours | vacation account
  • Your growth : Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
  • Your value : Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
  • Your health and lifestyle : Company bike
  • Your mobility : Job ticket | Deutschlandticket
  • Your life phases : Employer-funded pension | Childcare