Validation & Engineering Group, Inc.

General

• Provide risk-based validation services for Factorian, L7 ESP, and other assigned GxP computerized systems
• Review intended use, GxP impact, system architecture, supplier documentation, configuration, customization, interfaces, data flows, infrastructure dependencies, and SDLC evidence
• Define validation approaches and identify gaps
• Develop, revise, execute, and close lifecycle documents, including assessments, validation plans, specifications, risk assessments, supplier assessments, test protocols, traceability matrices, discrepancy records, summary reports, and release documentation
• Evaluate and test controls for access, roles and permissions, audit trails, electronic records and signatures, data integrity, interfaces, calculations, reports, time synchronization, backup and recovery, data migration, security, and system administration
• Execute approved testing, capture objective evidence, manage incidents and deviations, coordinate corrective actions and retesting, and maintain traceability through closure
• Ensure system changes and releases are governed through Change Control and required validation, procedural, training, data, and operational-readiness activities are complete
• Review qualification documents and evidence for assigned systems or equipment
• Confirm qualification boundaries, components, prerequisites, test strategy, acceptance criteria, and required documentation
• Perform field walkdowns and document reviews
• Generate IQ/OQ protocols, incorporate comments, and support approval routing
• Execute approved IQ/OQ protocols in accordance with company procedures and Good Documentation Practices
• Document discrepancies, exceptions, and deviations and provide technical information for resolution
• Coordinate authorized retesting after corrective actions
• Assemble executed protocols and supporting evidence into complete review packages
• Generate and maintain Requirements Traceability Matrices
• Generate Qualification Summary Reports describing scope, results, deviations, open items, and qualification status
• Support review-comment resolution and final approvals
• Maintain weekly forecasts, deliverable trackers, and time records

Computer System Validation Specialist

• Provide risk-based validation services for Factorian, L7 ESP, and other assigned GxP computerized systems
• Review intended use, GxP impact, system architecture, supplier documentation, configuration, customization, interfaces, data flows, infrastructure dependencies, and existing SDLC evidence
• Define validation approaches and identify gaps
• Develop, revise, execute, and close lifecycle documents including assessments, validation plans, specifications, risk assessments, supplier assessments, test protocols, traceability matrices, discrepancy records, summary reports, and release documentation
• Evaluate and test controls for access, permissions, audit trails, electronic records and signatures, data integrity, interfaces, calculations, reports, synchronization, backup and recovery, migration, security, and administration
• Execute approved testing, capture objective evidence, manage incidents and deviations, coordinate corrective actions and retesting, and maintain traceability through closure
• Ensure system changes and releases are governed through Change Control and that validation, procedural, training, data, and operational readiness activities are complete
• Review qualification documents and evidence for assigned systems or equipment
• Confirm qualification boundaries, prerequisites, test strategies, acceptance criteria, and documentation requirements
• Perform field walkdowns and document reviews
• Generate, route, execute, and support approval of IQ/OQ protocols
• Document discrepancies, exceptions, and deviations and provide technical information for resolution
• Assemble executed protocols and supporting evidence into complete approval packages
• Generate and maintain Requirements Traceability Matrices and Qualification Summary Reports
• Maintain weekly forecasts, deliverable trackers, and time records

• Provide risk-based validation services for Factorian, L7 ESP, and other GxP computerized systems
• Review intended use, GxP impact, system architecture, supplier documentation, configuration, customization, interfaces, data flows, infrastructure dependencies, and SDLC evidence
• Define validation approaches and identify gaps
• Develop, revise, execute, and close lifecycle documents, including assessments, validation plans, specifications, risk assessments, test protocols, traceability matrices, discrepancy records, summary reports, and release documentation
• Evaluate and test controls for access, roles, permissions, audit trails, electronic records and signatures, data integrity, interfaces, calculations, reports, time synchronization, backup and recovery, migration, security, and administration
• Execute approved testing, capture objective evidence, manage incidents and deviations, coordinate corrective actions and retesting, and maintain traceability through closure
• Govern changes and releases through Change Control and confirm validation, procedural, training, data, and operational readiness before release
• Review qualification documents and supporting records
• Confirm qualification boundaries, components, prerequisites, test strategy, acceptance criteria, and documentation requirements
• Perform field walkdowns and document reviews
• Generate, route, execute, and close IQ/OQ protocols
• Document discrepancies, exceptions, and deviations and support resolution
• Assemble executed protocols and evidence packages
• Generate Requirements Traceability Matrices and Qualification Summary Reports
• Support review comment resolution and final approvals
• Maintain weekly forecasts, deliverable trackers, and time records

• Lead qualification of the autoclave located in San Juan and associated water and Clean Steam Generation systems
• Review facility, design, commissioning, vendor, maintenance, calibration, operating, and prior qualification documentation
• Perform field assessments and walkdowns; confirm equipment, utility boundaries, interfaces, prerequisites, and readiness
• Develop or revise lifecycle documents, including URS, risk assessments, Validation Plans, IQ/OQ/PQ protocols, data sheets, RTMs, discrepancy/deviation records, and summary reports
• Define and execute qualification activities such as installation and utility verification, controls and alarm testing, cycle parameter testing, chamber distribution or mapping, load penetration studies, challenge testing, reproducibility, and acceptance criteria
• Verify or qualify supporting water and Clean Steam Generation systems, including generation, distribution, quality attributes, sampling, monitoring, controls, alarms, and interfaces
• Coordinate equipment availability, approved loads, calibrated instruments, biological or chemical indicators, sampling, laboratory support, safety requirements, and execution prerequisites
• Generate IQ/OQ protocols using Company procedures, templates, and document control processes; route protocols through approval
• Execute approved protocols according to Company procedures and Good Documentation Practices
• Document discrepancies, exceptions, and deviations; support assessment, corrective actions, resolution, and authorized retesting
• Assemble complete, inspection-ready qualification packages
• Generate and maintain Requirements Traceability Matrices and Qualification Summary Reports
• Support review comment resolution and final approval of qualification documents
• Maintain weekly forecasts, deliverable trackers, and time records
• Perform protocol execution and field activities on site in San Juan; document development may be remote when authorized

Autoclave and Supporting Utility Qualification Specialist

Engineer

• Lead and execute manufacturing process characterization studies
• Perform process capability assessments and data analysis
• Conduct manufacturing line evaluations and performance assessments
• Support process optimization and continuous improvement initiatives
• Provide equipment startup, troubleshooting, and operational readiness support
• Lead root cause investigations and support corrective actions
• Develop and execute engineering studies supporting manufacturing objectives and process improvements
• Collaborate with Manufacturing, Operations, Engineering, Maintenance, and Quality teams
• Develop and execute IQ, OQ, and PQ protocols
• Support qualification of new and existing manufacturing equipment and systems
• Execute system verification and validation activities
• Lead process validation planning, execution, data analysis, and reporting
• Provide commissioning and qualification support
• Support the full validation lifecycle from planning and protocol development through execution, deviation resolution, and final report approval
• Manage protocol deviations, exceptions, and associated investigations
• Support change control assessments and implementation activities
• Develop validation summary reports and final project deliverables
• Author, revise, and support approval of GMP technical documentation, including SOPs, batch records, manufacturing instructions, process evaluation reports, process characterization and validation protocols and reports, equipment qualification and system verification documentation, engineering study protocols and reports, risk assessments, technical assessments, change controls, and user requirements

Computer System Validation Specialist

Computer System Validation Specialist

Computer System Validation Specialist

Autoclave and Supporting Utility Qualification Specialist

Senior Process Engineer / CQV Validation Engineer