Quality Engineer
Title: Quality Validation Engineer
Location: North of Puerto Rico (Open to Puerto Rico Residents)
Positions: 1
6 months contract
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
Execute and/or approve:
OQ (Operational Qualification)
PQ (Performance Qualification)
TMV (Test Method Validation)
IPM (In-Process Monitoring)
Apply technical judgment to:
Confirm applicability of validation documentation and risk documentation
Identify discrepancies such as missing, conflicting, or outdated records
Ensure alignment with:
Current procedures
Global validation standards
Remediation expectations and timelines
Key Responsibilities
Validation Engineer
Validate multiple processes as needed/applicable following site practices and documentation
Cross-check validation records against:
MVPs (Master Validation Plans)
PRAs (Product Risk Assessments)
Supporting validation documentation
Identify and quantify products requiring remediation across OQ, PQ, TMV, and IPM
Highlight high-risk, complex, or ambiguous scenarios requiring deeper analysis