Agidens Nederland

Improvement. That's what Agidens is all about. We help our customers improve their processes and procedures. We support them by offering consulting and engineering services, by delivering turnkey automated solutions or by providing maintenance and support. We bring advancement by creating solutions that increase efficiency, quality, safety and reliability. Agidens hereby focusses on target markets such as life sciences, food & beverage, tank terminals, (petro) chemicals and infrastructure.

Agidens employs over 550 people and is active in six countries: Belgium (Headquarters), The Netherlands, France, Germany, Switzerland and the US. Together they reach a total order intake of 90 million euro. Ackermans & van Haaren (via Sofinim) is the main shareholder of the company. For more information visit www.agidens.com

To further support our growth we are constantly looking for talented and engaged employees that will help us realise our mission for progress. Because progress brings us together.

LIFE SCIENCES GxP COMPLIANCE - Computerized Systems Validation Consultant

To strengthen the Agidens Life Sciences team in the Netherlands, 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.

Function

• You develop the validation strategy and carry out validation activities on an R&D site or a production plant (Bio-Tech).
• 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.

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 Dutch and English, oral and written.

Offering

• To work in a dynamic environment where you can give free rein to your inventiveness within a well-defined framework.
• To have the possibility to team up with passionate, quality on technology-driven people.
• To develop yourself in a learning environment that offers the potential for career development.
• To be part of a company culture where respect, knowledge sharing, open mind, allow to strive for excellence.
• In this function you will be based in the region Leiden.


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