Objective
Support multiple new line development projects by executing Tool Qualifications (TQFs), Operational
Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), and In-Process
Monitoring (IPM) by leveraging automated tools and site-level expertise.
Scope of Work
o OQ (Operational Qualification)
o PQ (Performance Qualification)
o TMV (Test Method Validation)
o IPM (In-Process Monitoring)
- Apply technical judgment to:
o Confirm applicability of validation documentation and risk documentation
o Identify discrepancies such as missing, conflicting, or outdated records
o Current procedures
o Global validation standards
o Remediation expectations and timelines
Work Location: In person
