CSV Specialist

Consultys Benelux is looking for Computer System Validation (CSV) specialist for at least 3 years of experience in the Biopharma sector.

As a CSV specialist, you will contribue to the validation projects together with the customer’s team to achieve success and drive results. You will reinforce the customer team to increase efficiency, robustness and in time delivery of all required information and deliverables. 

The main role of the CSV specialist is to ensure the proper execution of Excel VBA qualification and validation activities in accordance with the Customer's validation methodology.

The duties of the Validation/Qualification Specialist are the following:

• Perform validation of VBA scripts in Microsoft Excel, VBA scripts have an interface with SAP for master data encoding
• Support the inventory of Excel template used
• Creation and follow-up of Technical Change Description
• Creation of IQOQ protocols
• Execution of IQOQ protocols
• Creation of IQOQ reports
• Manage documents related to validation in the Customer's document management system (from draft to approval)

Academic background:

• Pharmaceutical Sciences, Biology, Chemistry, Bio/Chemical Engineering or any other applicable scientific discipline

Technical skills:

• Have already demonstrated success in computerized system validation (Excel VBA), quality operations and project management Good knowledge of cGMP (data integrity aspect is key)
• Experience working with Biologics (if possible preferred over Pharmaceuticals)
• Experience in a operational role (Production, Validation, etc) is usefull to understand shopfloor issues and discussions.
• Good knowledge of Microsoft Excel: design, functions, macro and VBA.Good knowledge of Validation/Qualification process.
• Fluent in French & English

Soft skills :

• Good communication/negociation skills
• Ability to build relationships transversally across the Customer's network.
• Manages own time to meet agreed short-term targets
• Quality and rigour oriented mindset, ability to make synthesis over data analysis
• Ability to lead meetings with stakeholders from other sites/operating companies
• Creative approach to problem solving
• Team player and autonomous

Experience

• Minimum 3 to 5 years’ experience in a computer systems validation role.