Validation Engineer II
Job Responsibilities:
- Support validation project plans and protocols, as well as executing protocols and drafting final project reports
- Participate in equipment failure investigations, CAPAs, and equipment release
- Review and approve validation and calibration documentation
- Work with GE Kaye Validator and ValProbe data systems
Preferred Qualifications:
- 3+ years of experienced with process, equipment, utility, and/or software validation in a GMP regulated environment.
- Familiar with temperature chamber, sterilization, cleaning, software and depyrogenation qualifications
- Experience troubleshooting, investigating and effectively documenting deviations and discrepancies on project execution
- Experience with writing validation protocols, project plans and final reports and managing validation projects
- Knowledge of risk management tools and techniques
