Senior Validation Engineer: Lab Systems & Compliance Leadership

Veg Group; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Senior Validation Engineer to provide technical leadership for validation maintenance of QC laboratory and QA incoming systems, including periodic monitoring, qualification of autoclaves, isolators, and temperature-controlled equipment.

You will author and review validation protocols and reports, evaluate equipment history and deviations, coordinate data verification, and support regulatory audits across cross-functional teams.

Qualifications

• Bachelor’s degree in Engineering, Science, Microbiology, or a related field.
• Five or more years of equipment qualification or validation experience in FDA-regulated operations.
• Direct experience with autoclaves, isolators, controlled-temperature equipment, laboratory hoods, glass washers, or comparable laboratory systems.
• Experience with thermal mapping, temperature sensors, data loggers, calibration documentation, and qualification data analysis.
• Strong knowledge of cGMP documentation, validation lifecycle practices, deviations, CAPAs, and change control.
• Experience authoring and executing protocols and reports in Kneat, CDOCs, or comparable electronic validation systems.
• Strong technical writing skills in English.

Responsibilities

• Lead periodic monitoring and qualification activities for laboratory autoclaves and isolators.
• Review periodic assessments for controlled-temperature chambers, laminar-flow hoods, inspection booths, glass washers, and other QC/QA lab equipment.
• Author, review, execute, and obtain approval of validation protocols, reports, assessments, and supporting documents.
• Evaluate equipment history, calibration status, preventive maintenance, deviations, CAPAs, change controls, alarms, and operational performance.
• Coordinate thermocouple placement, temperature-mapping equipment, wireless data loggers, and other calibrated instruments.
• Provide technical support during regulatory audits, inspection interviews, and validated-state presentations.

Skills

Leadership

Technical writing

Regulatory compliance

Data verification

Validation lifecycle

Cross-functional coordination

Education

Bachelor’s degree in Engineering/Science

Tools

Kneat

CDOCs

Job description

Validation & Engineering Group, Inc. is seeking a Senior Validation Engineer to provide technical leadership for validation maintenance of QC laboratory and QA incoming systems, including periodic monitoring, qualification of autoclaves, isolators, and temperature-controlled equipment.

You will author and review validation protocols and reports, evaluate equipment history and deviations, coordinate data verification, and support regulatory audits across cross-functional teams.