Csv Validation Engineer

Description

VALIDATION ENGINEER - Computer system validation

A pharmaceutical organization, is seeking a CSV Validation Engineer, based in the Netherlands, Amsterdam area.

Project

The organization has a large backlog of validation files which need to be resolved quickly. Mainly within its operations department

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 21 CFR Part 11
*Knowledge of process equipment is a pro
*Experience with IT-systems and interfaces.
*Identifying and suggesting solutions for problems.
*Good communication and organizational skills.
*Ability to work on different tasks simultaneously.
*At least 4y relevant experience
*Extensive SDLC knowledge
*Experience in writing SOP computerized systems


Start ASAP