On behalf of a client modis is looking for a CSV engineer.
- Define the validation
- Leveraging the existing Validation Master Plan, validation SOPs and Data Integrity assessments defined at enterprise level.
- Define the validation approach for change controls based on scope and risk and help maintain validated state for regulated systems.
- Contribute and collaborate on CSV activities for enterprise-level, multi-site lab and manufacturing systems.
- Work collaboratively to ensure the development of CSV best practices to support the timely delivery of validated computer systems for internal clients.
- Fluency in English
- BS or relevant degree with at least 2-5 years of CSV experience in a GxP environment in the pharmaceutical industry.
- Experience defining the validation approach for computer systems.
- Experience working with l manufacturing systems and validating the associated software is desired.
- Ability to prioritize, good written and verbal communication skills.