- In collaboration with plant support functions, assist with planning, set up and implementation of Process Validation programs.
- Execute (protocol generation, execution, and final package preparation) process Validation activities related to Product Introductions and Change Control.
- Develop process validation plans for specific projects.
- Establish site process validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures.
- Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs.
- Lead and represent GMSAT Process validation in multi-departmental meetings and project teams.
- 3+ years experience in a cGMP regulated manufacturing environment.
- Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process and cleaning validation expectations.
