- Winnipeg, Manitoba, Canada
- Entry
- 5–7 years
Support validation efforts and lead projects to ensure equipment, facilities, utilities, processes and computer systems used in manufacturing are validated for intended use.
Responsibilities
- Review, assess and approve CSV related materials for all local and global Computerized System projects
- Apply Global GxP requirements as part of a pragmatic validation strategy for computerized systems
- Establish and enhance relationships between IT, validation, and business units
- Monitor effectiveness of the DI/CSV program and recommend optimization opportunities
- Participate in audits of DI/computerized systems
Requirements
- BS Engineering
- BS Chemistry
- BS Microbiology
- Nice to have: Aseptic/Sterile Manufacturing
- Nice to have: Qualification experience within pharmaceutical or biopharmaceutical industries