R&D Validation Engineer: Equipment IQ/OQ/PQ & Process Dev

Validation-; Dorado (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Pinnaql is seeking an R&D Validation Engineer to support equipment validation (IQ), tool qualification (TQF), and process development across R&D, PD, and manufacturing. The engineer will design fixtures, develop validation protocols, and generate documentation to ensure compliant, scalable operations.

Candidate will work cross-functionally to qualify new processes, perform data analysis, and contribute to DOE studies.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Experience with equipment validation and tool qualification in regulated settings.
• SolidWorks proficiency for fixtures and gages design.
• Strong knowledge of IQ/OQ/PQ and validation documentation.

Responsibilities

• Support equipment validation (IQ) and tool qualification activities (TQF).
• Review and develop equipment validation protocols and reports.
• Design, update and review tools and fixtures using SolidWorks.
• Qualify new processes and assist on DOE and sampling plans.
• Generate validation documentation and calibration procedures as required.
• Collaborate cross-functionally with PD, R&D, Quality, and Operations.
• Summarize results and prepare technical reports.

Skills

Equipment validation

Tool qualification

Process development

DOE

Data analysis

Cross-functional collaboration

IQ/OQ/PQ understanding

Regulated documentation

Education

Bachelor’s degree in Engineering

Tools

SolidWorks

Job description

Pinnaql is seeking an R&D Validation Engineer to support equipment validation (IQ), tool qualification (TQF), and process development across R&D, PD, and manufacturing. The engineer will design fixtures, develop validation protocols, and generate documentation to ensure compliant, scalable operations.

Candidate will work cross-functionally to qualify new processes, perform data analysis, and contribute to DOE studies.