CSV 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 Healthcare and Medical Devices organization, based in Noord-Brabant Netherlands.
You will be involved in the delivery of all validated projects.
ROLE DESCRIPTION
As a CSV Engineer you will have a vital role within the organisation in order to deliver validated projects within a large QMS program. You will control the process during the entire project life cycle.
RESPONSIBILITIES
- Guarantee validation procedures of IT applications and interfacing to the QMS
- Change control during new implementations and disentanglements of QMS
- Development of new validation strategy
- Compliance according to FDA and ISO13485
- Collaboration with validation engineers
REQUIREMENTS
- 5+ years' experience in Software QA / Validation
- 10+ years' experience in Software Life Cycle Process Development
- Experience with SAP migration projects
- Knowledge of SAP QMS and SAP HANA is a strong asset
- Previous experience with 21 CFR Part 11, ISO13485, GAMP and CSV
- Fluent in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Niek Schreurs.