Computerized System Validation (CSV) Consultant

Randstad
4000.00 - 5500.00
32-40 hours
Bachelor degree

Client

Our client is active in the food, life sciences, infrastructure, oil and gas and (petro) chemical markets by delivering:

Support through consulting & engineering;
delivering turnkey automated solutions;
maintenance and support.

Requirements

You preferably have at least a master or engineer’s degree in a technical or scientific field, linked to life sciences.
You have 5 years of experience with computer validation in a GMP environment and you know how to use some of its associated applications (ex.: MES, ERP, LIMS, EBR, QMS/eDMS, etc.).
You have broad/general knowledge on computerized systems and automation (ex.: data security, data exchange, infrastructure, PLC, SCADA, MES-systems, ERP, etc).
You are familiar with working according GAMP 5, and aware of current insights regarding 21 CFR-part11.
You are able to work precisely and accurately and in accordance to specific guidelines and rules (ex. GMP, GLP).
You have good communication skills at different (social) levels.
You are self-reliant and organized, with a team spirit.
You have experience with MS Office.
You express yourself fluently in English, oral and written. Dutch is a big plus.

What do you get?

Pension entitlement as from day one
Collective WGA / WIA insurance
NBBU / ABU collective labor agreement
25 holidays days
8,33% holiday allowance
100% payment in case of illness after one waiting day
Travel allowance

Duties

To strengthen the validation team of our client, we are looking for an experienced CSV Consultant. You will monitor the quality of processes, systems, equipment and/or software applications, used for research and production of medicines.

Description

You develop the validation strategy and carry out validation activities on an R&D site or a production plant.
You prepare ‘high level’ documents (validation master plans, criticality analysis), protocols and scripts, procedures and reports, up to the final delivery.
You may be conducted to supervise a team of validation engineers in the execution of validation activities.
You strictly work according procedures and guidelines.
You report on the progress of these validation activities to the project manager.