Agidens België

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 - Senior Computer System Validation Engineer

To strengthen the Agidens Life Sciences team, we are looking for a senior CSV engineer. You will monitor the quality of processes, systems, equipment and/or software applications, used for research and production of medicines. Thereby you are ensuring that only safe, effective medicines can be produced.

Function

  • You develop the validation strategy and carry out validation activities on an existing production plant and improve/modify different software applications.
  • You prepare ‘high level’ documents (technical specifications, operating procedures), ex: Validation master plans, criticality analysis.
  • You supervise a team of validation engineers in the execution of validation activities.
  • You strictly work according procedures and guidelines.
  • You, independently, work out technical improvement proposals.
  • You report on the progress of these validation activities to the project manager.

Requirements

  • You preferably have at least a Master degree in a technical field.
  • You have 5 years of experience with computer validation in a GMP environment.
  • You have a strong interest in automation.
  • You know how to use software applications in a GMP environment (ex.: MES, ERP, LIMS, EBR, date history, etc.).
  • You have broad/general knowledge on ICT and automation (ex.: data security, data exchange, infrastructure, PLC, SCADA, MES-systems, etc).
  • You are familiar with working according GAMP 5.
  • You are 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 independent.
  • You have experience with MS Office.
  • You express yourself fluently in Dutch and English.

Offering

  • To work in an environment where you can give free rein to your creativity within a well-defined framework and where intrapreneurship is encouraged.
  • To have the possibility to team up with passionate, technology-driven people.
  • To develop yourself in a learning environment that offers the potential for career development.
  • To be part of a culture of show respect, take ownership, be open minded, strive for excellence.

For any questions you can contact muriel.hemelaers@agidens.com or +32 3 800 76 62

Your application will be evaluated by the HR department of Agidens België itself. For any additional feedback regarding your application, we kindly refer you to the Agidens België HR department.


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