Senior Computer Systems Validation Specialist, Validation Lead

Our client, one of the biggest pharmaceutical companies based in the Basel area, is looking for a Validation Lead with strong understanding of CSV in a Pharmaceutical Manufacturing Execution System (MES) area.

This is a long term contracting role planned to start mid of March until the end of the year with extension opportunities.

Are you a Senior Computer Systems Validation Specialist with experience in validation for MES projects currently looking for your next challenging project?

Please have a look at the opportunity we can offer you:

Key Responsibilities

- Leads a project stream for validation with the objective to set up the CSV of a MES Program (initial Core validation + rollouts)
- Ensures the completion of CSV deliverables in time and in quality
- Ensures the alignment of the different stakeholders
- Collaborates with and gives regular updates to the Project Manager
- Authors, reviews and consults on validation documentation including but not limited to Test Scripts, Validation Plans, Installation Qualifications, SATs, UATs and Validation Reports
- Ensures compliance with corporate and global Roche standards (eg Roche-internal CSV policies, directives and SOPs or project management methodology) and legal requirements
- Escalates non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution
- Provides advice, expertise and trains others in the requirements for Quality Assurance and provides input to Informatics process improvement projects and other cross functional programs

Ideal Profile:

- Very good understanding of CSV in a pharmaceutical MES (ie over 7 years of work experience in the relevant area)
- 5+ years of experience in validation for MES projects
- Strong leadership skills (former work experience as a lead would be a big plus)
- Fluent in English (written and spoken)
- Flexible for business travels (up to 20%)
- Ability to communicate clear and effectively
- Ability to arbitrate between a wide range of stakeholders to come to a solution (former work experience with stakeholders would be a big plus)
- Experience in CSV for a global program will be a big asset
- Understanding of the MES process is an advantage
- Fluency in German is a big plus
- Project Management experience will be a nice to have

If you match the above skill set and are interested in this position, I look forward to receiving your application via this website.

Please note, we can only consider EU/CH candidates or those with a valid work permit for Switzerland.