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• Identify discrepancies such as missing, conflicting, or outdated records 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

1. 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