Description
VALIDATION ENGINEER - Computer system validationPharmaceutical client currently have a contract requirement for an experienced Computer System Validation Engineer for a contract role based in the Netherlands.
For this role we are looking for experienced CSV Engineers to work on the CSV of IT Systems & Process Equipment. This will also include working on a large backlog of validation files which need to be resolved, within the operations department.
For the execution of the tasks an additional resource is needed to write validation documents and execute the validation tasks.
Profile
For the execution of the tasks an additional resource is needed to write validation documents and executes the validation tasks.
Activity list:
* Write / Execute / Protocols
*Must be able to carry out validation lifecycle
* Functional Specifications
*Technical Specifications
*Unit Testing
*End to End Testing
*URS
*Acceptance Testing
*Validation reporting
Requirements
* Must be English for reading/writing.
*Experienced with medium to complex validation activities.
*Knowledge of regulatory requirements (GMP).
*Knowledge of process equipment is a pro
*Experience with IT-systems and interfaces.
*Extensive SDLC knowledge
*Experience in writing SOP computerized systems