Validation Engineer: Periodic Review & Lifecycle

Veg Group

Puerto Rico

On-site

USD 90,000 - 120,000

Full time

3 days ago
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Job summary

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

You will collect and evaluate lifecycle evidence, prepare periodic-review assessments, manage document workflows, and support maintenance of the validated state. Onsite work with flexible hours is expected.

Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
  • Three+ years in validation, qualification, quality engineering, or lab-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.
  • 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 history, maintenance status, deviations, and changes.
  • Prepare periodic-review assessments, reports, conclusions, recommendations, and action items.
  • Confirm 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 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 evidence in support of audits and inspections.
  • Maintain accurate execution status and KPI information.

Skills

Validation lifecycle experience
cGMP environment
Protocols/reports preparation
Change control / CAPAs
Onsite work / non-standard hours

Education

Bachelor's degree in Engineering or Life Sciences

Tools

Kneat
CDOCs
Maximo
LIMS
TrackWise

Job description

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

You will collect and evaluate lifecycle evidence, prepare periodic-review assessments, manage document workflows, and support maintenance of the validated state. Onsite work with flexible hours is expected.

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