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Validation Engineer (gn) (EN)

[5158]
Medical, Pharma-, Medizinprodukte, Prozessplaner, Produktion

As part of our client's team, you will play a central role in finding solutions to some of the biggest scientific challenges of our time.  Our client's goal is to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel treatments for cancer and infectious diseases. We are looking for a dedicated individual to join us as soon as possible as a Validation Engineer (gn) Your tasks ·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 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 Your qualifications ·University degree in (Life) Science, Engineering or a medical field ·Practical experience in the life science industry, working together with Contract Manufacturing Organizations ·Strong expertise in validation engineering, ability to write, read and interpret engineering specifications and work collaboratively with equipment supplier engineers as well as internal engineering team ·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 You will be offered ·Company Pension Scheme ·Childcare ·Jobticket ·Company Bike ·Leave Account ·Fitness Courses ·Mobile Office ·Special Vacation ... and much more

As part of our client's team, you will play a central role in finding solutions to some of the biggest scientific challenges of our time. 
Our client's goal is to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel treatments for cancer and infectious diseases.

We are looking for a dedicated individual to join us as soon as possible as a


Validation Engineer (gn)

Your tasks
  • 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 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


Your qualifications

  • University degree in (Life) Science, Engineering or a medical field
  • Practical experience in the life science industry, working together with Contract Manufacturing Organizations
  • Strong expertise in validation engineering, ability to write, read and interpret engineering specifications and work collaboratively with equipment supplier engineers as well as internal engineering team
  • 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


You will be offered

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

map Region Mainz date_range 01.11.2021 update Permanent
Medizinprodukte Pharma- Medical Produktions-


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