Senior CSV Consultant

For our client, a leading Life Sciences company with headquarters in the Basel area, Swisslinx are searching for a highly motivated Senior CSV Consultant on 6 month contract that is likely to be extended.

Senior CSV Consultant

Process analytical technologies (PAT) are used to monitor the quality attributes of the product during processing in real time. In R&D PAT provides better process understanding through monitoring during drug product and drug substance development. PAT can also contribute to a more reliable scale up and for some products PAT is needed for reliable process control.

The PAT project is an integrated part of our effort to speed up development and production of drug products. The core system is used for processing, reporting, and storage of PAT data from different PAT systems with probes.

Tasks and Responsibilities include:

- Computerized system validation of stand-alone systems according to Roche requirements

- Authoring of the system dedicated SOPs and other CSV documentation

- Communication with stakeholders across the organization

- Collaboration with the project team

- Report to the CSV Lead

What to bring:

- +8 years of experience as CSV Specialist (requirements below included)

- Experience with validation of lab systems in a GMP environment

- More than 4 years of experience in regulated environments

- Project management experience

- Experience in cooperation with lab and service technicians

- Experience in operating different Lab IT systems

- Strong communication skills

- Fluent in German and English (both mandatory)

-Experience with validation of PAT systems is a plus

-Experience with Roche is a plus

-Experience with HP ALM Software is a plus

This position offers a fantastic opportunity for a candidate to gain experience with one of the world’s leading life sciences companies.

Would you like to learn more about this unique opportunity? Then please apply online.  We look forward to hearing from you!