Computer System Validation Engineer - Dutch Speaking

Job type:
on-site
Start:
May 2012
Duration:
3 months + Extension likely
From:
Quanta Consultancy Services
Place:
Noord-Holland
Date:
04/17/2012
Country:
flag_no USA
project ID:
349962

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This project is archived and not active any more.
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Pharmaceutical 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 fluent in Dutch and English to work on the CSV of IT Systems & Process Equipment such as: freeze driers, check weighers. 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.

Activity list:

-Write/Execute/Protocols
-Must be able to carry out validation life cycle
-Functional Specifications
-Technical Specifications
-Unit Testing
-End to End Testing
-URS
-Acceptance Testing
-Validation reporting
-Data Acquisition
-GAP analysis/Trace ability Matrix

To be successful for this role you will have the following skills/experience:-
-Must be Dutch speaking/reading/writing
-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