Validation Quality Engineer

Responsibilities

• Execute and approve OQ (Operational Qualification), PQ (Performance Qualification), TMV (Test Method Validation), and IPM (In-Process Monitoring)
• Apply technical judgment to confirm the applicability of validation and risk documentation
• Identify discrepancies such as missing, conflicting, or outdated records
• Ensure alignment with current procedures, global validation standards, and remediation timelines
• Cross-check validation records against Master Validation Plans (MVPs) and Product Risk Assessments (PRAs)
• Identify and quantify products requiring remediation across various validation stages
• 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

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related field
• 3+ years of experience in Validation (OQ/PQ/TMV/IPM) and Quality Engineering
• Strong understanding of the validation lifecycle and regulated environments (FDA, ISO, GMP)
• Proficiency in advanced Excel for data analysis
• Fluency in both Spanish and English

Preferred Qualifications

• Experience with Windchill or similar document management systems

About the Company

Avante Engineering LLC was founded in 2019 with a vision centered on delivering a personalized approach to engineering and technical services. We provide expert consultation, project management solutions, and technical services to clients within the Bio/Pharmaceutical industry.