Validation Engineer
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands.
A global leader that designs and contract manufactures components and finished products sold into the commercial, drug-delivery and medical device market.
ROLE DESCRIPTION
The Validation Engineer is Responsible for preproduction related validation and verification processes and can assure that the product development processes and the applicable documentation are executed according to the agreed Product specific Design and Development Plans. Reporting and operating under the direction and guidance of the Design Assurance Manager, based in The Netherlands.
RESPONSIBILITIES
- Validation coordination, monitoring and approval
- Developing validation documentation
- Drafting and maintaining validation plans and requirements
- Validation training
- Validation reporting
- Lead and participate in risk management sessions
- Participating in client meetings, acting as validation & quality responsible person for projects
REQUIREMENTS
- Applicable technical or academic education, for example, engineer (the FDA requires validation training by an outside entity no later than 6 months from job start date.)
- ISO 13485, ISO 15378, ISO2859, ISO3951 and regulatory requirements (incl. 94/42-EEC, 21CFR Part 820)
- Knowledge of GMP and GAMP
- Plastics materials basics, the construction and technologies of injection moulding tools and automation.
- Implemented Quality Management System
- Eagerness to learn
- Customer interaction
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.
