MANAGER OF VALIDATION SERVICES
Oversee and lead the implementation and validation of production equipment and processes used in
cellular manufacturing as part of company's global CMO business. Lead a team of Validation Associates to establish and maintain a validated state of cell based manufacturing and coordinate technology transfer to/from other sites as needed. Support manufacturing to satisfy the quality and process validation requirements for existing products in a rapid growth environment as well as participate in the development and validation of new products, as needed. Also serve as a technical resource to improve product quality, reliability, and process capability.
1. Assess new and existing processes (including Equipment PQ, Process and Cleaning Validation,
etc.) against cGMP requirements for process validation and determine when re‐validation is
2. Develop and implement strategy for equipment IQ/OQ/PQ, process validation, test method
validation, and spreadsheet validation.
3. Perform functional and process risk assessments in conjunction with Quality and Operations
subject matter experts.
4. Oversee development and execution of validation protocols and review objective evidence for
inclusion in validation reports.
5. Manage documentation and resolution of deviances and variances that occur during validation.