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Biologist, Pharmacist - Validation Engineer, RNA Production (m/f/d) job in Mainz bei BioNTech SE

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Biologist, Pharmacist - Validation Engineer, RNA Production (m/f/d) bei BioNTech SE

Biologist, Pharmacist - Validation Engineer, RNA Production (m/f/d)

BioNTech SE Mainz, Rheinland-Pfalz Vollzeit
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Become a member of the BioNTech Family!

As a part of our team of more than 2.500 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Validation Engineer*

As Validation Engineer* you will be making a meaningful contribution to the ongoing development of our RNA production processes. To support us on our mission, you will create and implement validation concepts for process, packaging, cleaning and change management to ensure regulatory and Good Manufacturing Practices (GMP) compliance of Contract Manufacturing Organizations (CMOs). Your main responsiblities are:
  • Improving and constantly assessing effectiveness of validation plans, monitoring KPIs across CMOs and ensuring Lessons Learnt exchange
  • Defining and implementing the validation strategy across the product life cycle and ensuring adherence to defined standards across CMOs
  • Setting up validation risk assessments and controling of validation protocols to ensure compliance with standards and GMP requirements
  • Offering knowledge transfers to technical teams at CMOs, advice in regulatory and BioNTech compliant implementation of validation strategies
  • Collaborating with R&D to ensure knowledge transfer and creation for new/modified product validation strategies and adaptation of the same to CMO requirements with GMP compliance
What you have to offer.
  • University degree in (Life) Science, Engineering or a medical field
  • Practical experience in minimum 3 years in the life science industry (ideally a biotech or pharmaceutical company), working together with Contract Manufacturing Organizations
  • Strong expertise in validation (among others: process validation) ability to write, read and interpret Manufacturing/engineering specifications
  • In-depth knowledge of relevant US & EU regulations, EMA, FDA and other regulatory standards as well as Good Manufacturing Practices (GMP)
  • High team spirit and excellent collaborating skills
  • Critical, analytical, risk-conscious and solution-oriented thinking as well as structured and precise way of working, high detail-orientation and conscientiousness
  • Fast perception and high personal commitment within a fast paced environment
  • Good process management skills, Lean and Six Sigma qualifications preferred
  • Creativity and the ability to develop a flexible approach to changing conditions
  • Good communication skills, fluency in German and English
Benefits for you.
  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.
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Job ID: 163320