Cleanroom consultant

Bedrijfsnaam: -
Plaatsingsdatum: 26/08/2018
Standplaats: -


SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Brabant Flamand Belgium.The CompanyThis organisation is developing high-technology products across the globe. They established multiple subsidiaries worldwide that all have their own specialty. They are focused on the improvement of our health within society. They are specialists in 3D printing for the Medical and Healthcare industry.

Role DescriptionIn your role as cleanroom expert, you will be involved with the quality, clinical operations and production site. This company is designing a cleanroom class 7 and therefore, they are looking for support. On a daily basis you will be coordinating and providing advice for the set-up of the related procedures and operational strategies. You will be responsible for trainings, gowning procedures and best practices. Additionally, you will assist to create the best strategy for market access and for the launch of sterile products. This project is part-time for 2 days a week, therefore perfect to combine with other projects. The duration is estimated for minimal 6 months with a possibility for extension.

Responsibilities• Advisor and guide in cleanroom processes
• Overviewing the ongoing changes and points of improvement within the process
• Set up procedures and strategies for the compliancy of the cleanroom on an operational level
• Follow up on the latest developments for Medical Device regulation and creating strategies for the market access and
product launch of sterile products
• Follow up on the implementation and validation of cleanroom class 7

Requirements• Bachelor in Engineering
• Minimal 6 years of experience in the Medical Device industry
• Excellent knowledge of ISO 13485 and ISO 14644 standards
• Experience with various cleanroom processes and the operationalization of processes
• Critical scope and eye for detail
• Strong organisational skills
• Fluency in English and preferably Dutch or French

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
5 - 10 jaar
Contactgegevens :