Validation Inventory & Remediation Analyst
Techengpr, Dorado, Dorado, United States
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judgment to confirm the applicability of validation records and identify discrepancies such as missing, conflicting, or outdated documentation.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)
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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)
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