Validation Engineer, Medical Devices - Process Development

ProQuality Network; United States; Híbrido; USD 70.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Descripción de la vacante

ProQuality Network is seeking a Validation Engineer - Process Development in Puerto Rico to drive IQ/OQ/PQ activities, develop Master Validation Plans, and author validation protocols in a regulated medical devices environment.

The role partners with Process Development, Quality, Engineering, and Regulatory teams to ensure compliant validation, robust documentation, and continuous improvement, while supporting cross-functional product and process innovations.

Formación

• Bachelor’s degree in Engineering or related field.
• 3–5 years of experience in process or equipment validation in a regulated industry (medical devices preferred).
• Strong understanding of IQ/OQ/PQ, validation lifecycle, and cGMP principles.
• Experience developing validation protocols, technical reports, and Master Validation Plans.

Responsabilidades

• Support process and/or equipment validation activities (IQ, OQ, PQ), including PPQ and Master Validation Plans.
• Develop, review, and approve validation protocols, reports, and related documentation.
• Collaborate with Process Development to qualify new processes, including sampling plans and procedures.
• Design and implement in-process and receiving quality systems for new processes and components.
• Prepare and maintain equipment documentation, including entries, evaluations, PMs, and calibration procedures.
• Define appropriate gauges, tools, and equipment for test method development.
• Generate manufacturing instructions and process documentation for new production lines.
• Partner with cross-functional teams (Quality, Engineering, Manufacturing, Regulatory) to achieve process development goals.

Conocimientos

Process validation

IQ/OQ/PQ

cGMP principles

Documentation

Educación

Bachelor’s degree in Engineering

Descripción del empleo

ProQuality Network is seeking a Validation Engineer - Process Development in Puerto Rico to drive IQ/OQ/PQ activities, develop Master Validation Plans, and author validation protocols in a regulated medical devices environment.

The role partners with Process Development, Quality, Engineering, and Regulatory teams to ensure compliant validation, robust documentation, and continuous improvement, while supporting cross-functional product and process innovations.