Medior CSV Consultant

Consultys is looking for an Medior CSV Engineer to join its consulting team and support projects in Wallonia.

As CSV Engineer, your role is to plan, write, implement improvements, and review key documentation as well as to ensure the integrity and compliance of computerized system according to pharmaceutical regulations.

YOUR MAIN DUTIES:

• Define and monitor CSV qualification/validation strategies.
• Assess the qualification impact inherent in the risks identified.
• Draft qualification documents in accordance with qualification/validation SOPs.
• Identify the approach for implementing these strategies (Change Control, other).
• Plan, organise and coordinate validation activities, in conjunction with the project team.
• Carrying out and/or checking the qualification/validation tests on installations, involving future users and in accordance with the procedures in force.
• Reporting any problems that have an impact on the implementation schedule of said projects to his/her line manager.
• Provide CSV support for the activities of the Site Process Validation department (management of deviations, CAPA, preparation and/or participation in audits, etc.).
• Use its CSV expertise to respond to specific issues (position papers, risk analyses, etc.).

ABOUT YOU:

• Bachelor or Master’s degree in pharmaceutical sciences field and/or industrial automation
• Minimum 2 years’ experience in a pharmaceutical environment, including a proven experience in Computerized System Validation or Automation
• Good knowledge of GMP environment
• Knowledge of TIA Portal, SCADA or OSI PI
• Understanding of quality management systems (e.g., ISO 9001).
• Autonomous, conscientious and positive problem-solving mindset
• Fluency in French and English is mandatory (Dutch is a plus)

ABOUT US:

For more than 15 years, the largest laboratories in the world have been showing their confidence in our company. Specialized in pharma, biotech and medical devices, we support our customers from research to product launch.

We cultivate a human-scale company spirit that allows us to personally follow our 550 employees – each of them known for their technical and scientific expertise. Through our regional subsidiaries in France, Belgium, Canada and Switzerland, we offer everyone geographical stability, without a mobility clause in the contracts.

Do you want to integrate the consulting world into a human-sized company that values the individual and the performance? Do you want to invest in long-term innovative projects? To share your skills in a close-knit team where experiences are shared freely? So, join us! We offer you an attractive salary and fringe benefits. You will work in a stimulating international environment, with numerous opportunities for personal development.