Validation Inventory & Remediation Analyst

Techengpr; Dorado (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

Techengpr is looking for a Validation Inventory & Remediation Analyst in Dorado, Puerto Rico. The role involves supporting inventory analysis across various validation activities, leveraging automated tools, and collaborating with experts to ensure data accuracy. Candidates should have a Bachelor’s degree in Engineering or Life Sciences and 3+ years of experience in validation or quality engineering, along with strong data analysis skills and experience in regulated environments.

Qualifications

• Minimum of 3 years of experience in Validation (OQ/PQ/TMV/IPM) or Quality Engineering.
• Strong understanding of Validation lifecycle and documentation in regulated environments.
• Proficient in advanced Excel for data analysis.

Responsibilities

• Utilize automated tools to extract and organize validation documentation.
• Review and validate extracted data for accuracy and completeness.
• Perform detailed assessments to identify remediation scope.
• Identify and prioritize high-risk products needing remediation.
• Document findings and provide recommendations for remediation.

Skills

Validation (OQ/PQ/TMV/IPM)

Quality Engineering

Data analysis (Excel - advanced)

Document management systems (Windchill preferred)

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Job description

Validation Inventory & Remediation Analyst

Technical & Engineering Consulting is seeking a qualified candidate to support inventory analysis and define the scope of remediation activities across Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), and In-Process Monitoring (IPM). This role will leverage automated tools and collaborate with site-level subject matter experts to ensure data accuracy, completeness, and alignment with current validation standards and remediation requirements.

Key Responsibilities

• Utilize automated tools to extract, filter, and organize validation documentation (e.g., Windchill to Excel trackers) for remediation assessment activities.
• Review and validate extracted data to ensure accuracy, completeness, and alignment with site practices and documentation.
• Perform detailed assessments to identify remediation scope across Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), and In-Process Monitoring (IPM).
• Apply technical judgment to confirm the applicability of validation records and identify discrepancies such as missing, conflicting, or outdated documentation.
• Cross-check validation records against Master Validation Plans (MVPs), Product Risk Assessments (PRAs), and other supporting validation documents.
• Identify, quantify, and prioritize products or processes requiring remediation, including high-risk, complex, or ambiguous scenarios.
• Ensure alignment with current procedures, global validation standards, and remediation expectations and timelines.
• Proactively identify data gaps, inconsistencies, and tool limitations, and elevate risks, uncertainties, or blockers to the core team in a timely manner.
• Document findings clearly and provide recommendations to support effective remediation planning and execution.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3+ years of experience in:
  • Validation (OQ/PQ/TMV/IPM)
  • Quality Engineering or Manufacturing Engineering
• Strong understanding of Validation lifecycle and documentation and regulated environments (FDA, ISO, GMP)
• Experience with data analysis tools (Excel – advanced) and document management systems (e.g., Windchill preferred)