Validation Expert (M/F)

Posted 31 Jul 2020

Molsheim, Alsace - France

Req Id 208658

Details

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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 :

The BioMonitoring Research and Development organization develops new products and equipment for our microbiology laboratories customers in the pharmaceutical and food industry. You are an important contributor in the development project teams, in charge of ensuring the validation of our solutions in accordance with the requirements of our customers: GMP, GAMP, ICH guides, ISO standards.

In the project team, you lead upstream risk assessment on specifications and support functional risk analysis. You define the product validation strategy during its development and commissioning, to guarantee its quality and compliance with regulations and specifications. You write the VMP. You organize and document the validation work. To this end, you help to define plans and methods to characterize, verify and validate the performance of the equipment, based on risk analysis. You develop guides and validation plans for the end user to allow our field validation teams to carry out QIQOs at the customer's site.

You contribute to the implementation of product quality documentation, in collaboration with production and subcontractors.

In the R&D validation team, you contribute to regulatory monitoring and continuous improvement of validation practices and tools.

 

Who you are :

  • License, master or engineer in a scientific or technical field
  • 5 years of experience in the pharmaceutical industrial environment, in validation activities (FAT, SAT, IQ OQ PQ) on ideally automated processes.
  • Experienced working in project mode, ideally in a complex and multidisciplinary technical activity.
  • Autonomous, rigorous, organized and good communication skills. As a member of an R&D organization, you are curious and eager to bring innovative solutions to our customers.
  • Good level of English, written and oral. Ability to work in a multicultural organization.
  • Quality Knowledge: risk analysis methodologies, experience of Good Manufacturing Practices ideally in aseptic production, first experience of GAMP. Statistical analysis of the data (capability, design of experiment, ANOVA)

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

We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

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