Lifecycle Validation Engineer: Periodic Reviews

Veg Group; Barceloneta (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Validation Engineer for Periodic Review and Lifecycle to execute equipment periodic reviews and lifecycle documentation for QC/QA laboratory systems. You will collect evidence, prepare assessments, manage documents, and support audits to ensure continued validated state.

Onsite work with non-standard hours as required. Preference for experience with Kneat, CDOCs, Maximo, LIMS, and TrackWise to streamline documentation and lifecycle management.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• Three or more years of validation, qualification, quality engineering, or laboratory-equipment experience in a cGMP environment.
• Experience preparing protocols, reports, periodic reviews, validation assessments, or lifecycle documentation.
• Working knowledge of change control, deviations, CAPAs, calibration, and preventive-maintenance records.
• Experience with Kneat, CDOCs, Maximo, LIMS, TrackWise, or equivalent systems is preferred.
• Ability to work onsite and support non-standard execution hours as required.

Responsibilities

• Execute periodic reviews according to applicable procedures and approved master plans.
• Collect and evaluate equipment information, including validation and qualification history, calibration and preventive-maintenance status, deviations, CAPAs, and change controls.
• Prepare periodic-review assessments, reports, conclusions, recommendations, and action items.
• Confirm that systems remain suitable for their intended use and in a validated state.
• Author and revise protocols, reports, SOPs, validation assessments, and supporting documents.
• Route documents through Kneat, CDOCs, or other approved document-management systems.
• Address reviewer comments and facilitate timely document approval.
• Perform protocol execution, field verification, data collection, and independent data verification.
• Support discrepancy investigations, invalid or failed runs, deviations, and corrective actions.
• Update validation master plans, equipment inventories, schedules, and deliverable trackers.
• Provide documentation and technical evidence in support of audits and inspections.
• Maintain accurate execution status and KPI information.

Skills

Validation experience

Quality engineering

Education

Bachelor’s degree

Tools

Kneat

CDOCs

Maximo

LIMS

TrackWise

Job description

Validation & Engineering Group, Inc. seeks a Validation Engineer for Periodic Review and Lifecycle to execute equipment periodic reviews and lifecycle documentation for QC/QA laboratory systems. You will collect evidence, prepare assessments, manage documents, and support audits to ensure continued validated state.

Onsite work with non-standard hours as required. Preference for experience with Kneat, CDOCs, Maximo, LIMS, and TrackWise to streamline documentation and lifecycle management.