Quality Engineer
ProQualityNetwork
Job Description
Job Description
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- Identify discrepancies such as missing, conflicting, or outdated records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
Vacancy posted 1 day ago
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