Social network you want to login/join with:
Computer System Validation Engineer, Mechelen
Client:
Ordina
Location:
Mechelen, Belgium
Job Category:
Other
EU work permit required:
Yes
Job Reference:
6df9ac043b21
Job Views:
22
Posted:
23.01.2025
Expiry Date:
09.03.2025
Job Description:
Your Impact
As an experienced Computerized System Validation (CSV) Engineer, you play a key role in the implementation and management of software systems used in the Life Sciences sector. More specifically, your mission is to ensure the quality and regulatory compliance of software systems used across all GxP areas. Systems in scope include site specific lab instruments (e.g. HPLC software), production equipment (e.g. capsule filling machine), but also globally used web applications, medical devices, Clinical Trial Management Systems, complex Manufacturing Execution Systems, SAP,
Your responsibilities include:
* You advise the customer regarding the applicable regulations for your project/system.
* You are responsible for defining and documenting a risk based validation approach for your project/system.
* You plan and manage all validation activities required for your project/system.
* You (co )write validation documentation (e.g. Validation Plan/Report, System Criticality Assessment, User Requirements, ) and testing documentation (Test Plan/Report, Test Scripts, ).
* You are in close contact with various system/project stakeholders and understand the interests and needs of business, IT and Quality Assurance.
* You (co )write procedures (SOPs, Work Instructions) related to the use of your system.
* You are responsible for keeping your system in a validated state.
* You are able to provide system specific validation support during audits and inspections.
Where you''re going to get started
Ordina''s Quality & Compliance (Q) team provides more than 100 expert consultants in 3 different practices: Laboratory, Production, and Business Technology. Within these practices, different roles are taken up by the Q&C engineers such as qualification and validation of equipment, production lines, cleaning, sterilization, utilities, software, as well as business analysis, engineering, building, project management and much more. Most of the Q''ers have a scientific background; often industrial engineers, bioengineers, biotechnologists, biomedical scientists, pharmacists, but historians, translators/interpreters, communication scientists, etc. also regularly find their way to our team.
This is you
1. Graduate with a Master''s degree in a scientific direction (Industrial Engineer, Bio Engineer, Chemistry, Biotechnology, Pharmacy,...) or equivalent by experience.
2. Familiar with regulatory standards and guidelines (GAMP5, EU Anne