Validation Engineer: Periodic Review & Lifecycle Specialist

Veg Group; Northern (KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Validation Engineer for Periodic Review and Lifecycle to execute equipment periodic reviews and lifecycle documentation for QC and QA systems.

You will collect lifecycle evidence, prepare assessments, manage document workflows, and support the maintained validated state. The role involves protocol execution, data collection, deviations handling, and KPI tracking in a cGMP environment.

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

Documentation

Quality engineering

cGMP experience

Onsite work

Attention to detail

Education

Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline

Tools

Kneat

CDOCs

Maximo

LIMS

TrackWise

Job description

Validation & Engineering Group, Inc. is seeking a Validation Engineer for Periodic Review and Lifecycle to execute equipment periodic reviews and lifecycle documentation for QC and QA systems.

You will collect lifecycle evidence, prepare assessments, manage document workflows, and support the maintained validated state. The role involves protocol execution, data collection, deviations handling, and KPI tracking in a cGMP environment.