Validation Quality Engineer

Weil Group • Dorado, PR

2d

About The Position

We are looking for a Validation Quality Engineer to 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.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3+ years of experience in Validation (OQ/PQ/TMV/IPM)
• 3+ years of experience in Quality Engineering
• Strong understanding of Validation lifecycle and documentation
• Strong understanding of Regulated environments (FDA, ISO, GMP)
• Experience with Data analysis tools (Excel – advanced)
• Experience with Document management systems (e.g., Windchill preferred)
• Strong analytical and problem-solving skills
• High attention to detail and data integrity
• Ability to apply technical judgment in ambiguous scenarios
• Effective communication and escalation skills
• Ability to work independently in a fast-paced, high-priority environment

Nice To Haves

• Experience with Windchill

Responsibilities

• 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of validation documentation and risk documentation, and identify discrepancies such as missing, conflicting, or outdated records.
• Ensure alignment with current procedures, Global validation standards, and remediation expectations and timelines.
• Validate multiple processes as needed/applicable following site practices and documentation.
• Cross-check validation records against MVPs (Master Validation Plans), PRAs (Product Risk Assessments), and 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.
• Proactively identify data gaps, inconsistencies, and tool limitations.
• Escalate risks, uncertainties, or blockers to the core team in a timely manner.
• Provide clear documentation of findings and recommended actions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level