Validation Engineer Periodic Review and Lifecycle

Veg Group; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

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

Current job opportunities are posted here as they become available.

Validation Engineer Periodic Review and Lifecycle

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a Validation Engineer Periodic Review and Lifecycle to execute equipment periodic reviews and related lifecycle documentation for QC and QA laboratory systems. The position will collect and evaluate lifecycle evidence, prepare periodic-review assessments, manage document workflows, and support maintenance of the validated state.

• Validation Engineer Periodic Review and Lifecycle

Key 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.
  • Alarm, failure, repair, and performance history.
  • SOP and training status.
  • Previous periodic-review commitments.
  • Open actions and system improvements.
• 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.

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.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.