Validation Engineer* Quality Control

  • Work experience
  • IT
  • Software Development
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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* Quality Control

The Digital Solutions Quality Team is responsible for the design, implementation and operation of computerized systems that support the processes of BioNTech’s pharmaceutical quality control units (e.g. LIMS, Scientific Data Management Systems, chromatography systems). For these important projects the Digital Solutions Quality Control team is looking for the support of a Validation Engineer, responsible for computerized systems validation activities in corporation with the team.  

Your main responsibilities are:
  • Initiation of change requests and high level GMP risk evaluations
  • Maintain oversight of validation activities and traceability
  • Validation related stakeholder management (site QA, Process Owner, System Owner, etc.)
  • Coordination of validation activities in cooperation with project management 
  • Creation of validation plans and reports in coordination with the validation department
  • Creation of test plans, test reports
  • Preparation and moderation of risk analysis workshops
  • Management and tracking of testing activities
  • Management and tracking of Validation Documents

What you have to offer.

  • Master’s degree in computer science or life science with at least 5 years of relevant experience in pharmaceutical industry
  • Strong knowledge of regulatory requirements on computerized systems originating from CFR 21 Part 11, EU GMP Annex 11, etc.
  • Experienced with the planning and execution of Computer System Validation projects
  • Experienced with implementation and operation of laboratory systems in the pharmaceutical quality control area
  • Experienced with LabWare LIMS is beneficial
  • Very good pharma and biotechnology process knowledge
  • Strong communication and management skills
  • Structured and precise way of working

Benefits for you.

  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
  • Mobile Office
  • Special Vacation
... and much more.

Have we kindled your pioneering spirit?

Then apply now for our location Mainz and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 5437 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

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https://biontech.de