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Digital Platform Senior Validation Engineer (all genders)

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

Your role : You will be responsible for the guidance and direction of validation projects covering all the Life Science digital products, control systems, applications, computerized systems, software / OT (operational Technology-industrial software, cloud based solutions).  You will provide expert guidance on all aspects of computerized systems validation and will directly assist regulatory inspections and audits. The role will provide validation and quality assurance support for computerized systems, digital products, Process Controls systems, software systems, and IT infrastructure that have been newly developed, installed, upgraded, replaced and / or modified for the use in cGMP area. Performing 21 CFR Part 11, Annex 11 and all levels of risk assessments, writing white papers, validation protocols / reports and managing operation controls (change control, periodic review including customer complaints) for multiple digital products / software applications will be part of the responsibility.

 

Who you are :

  • Bachelor’s degree in chemical, computer science, bio medical, engineering or life science discipline
  • 6+ years of validation experience handling of multiple projects and quality assurance
  • Good written and verbal skills in English
  • Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes
  • Global travel required based on the need of project and business

 

 

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

Job Requisition ID:  244826
Location:  Darmstadt
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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