R&D Validation Engineer: IQ/OQ/PQ & Tool Qualification

Validation & Engineering Group, Inc.; Dorado (PR); Presencial; USD 80.000 - 120.000; Jornada completa

Descripción de la vacante

Pinnaql seeks an R&D Validation Engineer to support equipment validation (IQ), tool qualification (TQF), and process development across R&D, PD, and manufacturing. The role involves developing and executing validation protocols, designing fixtures, generating documentation, and supporting new technology evaluations.

You will work cross-functionally to qualify new processes and ensure compliant, scalable operations.

Formación

• Bachelor’s degree in Engineering or related field required.
• 2–5+ years of equipment validation, tooling qualification, or related regulated environment preferred.
• Proficiency with SolidWorks for fixture/tool design and review.
• Strong knowledge of IQ/OQ/PQ, validation documentation, and equipment lifecycles.
• Experience designing or supporting test methods, sampling plans, and quality systems.
• Ability to perform complex data analysis and generate technical reports.

Responsabilidades

• Support equipment validation (IQ) and tool qualification activities (TQF).
• Review and develop equipment validation protocols and reports; assist other functions during validation.
• Design, update, and review tools and fixtures to meet test methods and product needs using SolidWorks.
• Collaborate with PD/R&D, Quality, and Operations to qualify new processes.
• Generate equipment documentation, calibrations, and procedures as required.
• Develop in-process and receiving quality systems for new processes and components.
• Summarize results, generate technical reports, and maintain lab notebooks.

Conocimientos

SolidWorks

IQ/OQ/PQ

Validation principles

DOE

Data analysis

Cross-functional comms

Documentation

Regulatory compliance

Educación

Bachelor’s degree in Engineering

Herramientas

Minitab

SolidWorks

Descripción del empleo

Pinnaql seeks an R&D Validation Engineer to support equipment validation (IQ), tool qualification (TQF), and process development across R&D, PD, and manufacturing. The role involves developing and executing validation protocols, designing fixtures, generating documentation, and supporting new technology evaluations.

You will work cross-functionally to qualify new processes and ensure compliant, scalable operations.