Equipment Validation Engineer — On‑Site, Hands‑On Impact

Pinnaql, Inc.; Humacao (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a dedicated Equipment Validation Specialist to lead hands-on IQ/OQ/PQ execution and qualification activities.

The role requires performing risk assessments and supporting change controls, plus assisting in commissioning and handover to operations. Ideal candidates hold a Bachelor’s in Engineering or related science and have 2–5 years in equipment validation, preferably with medical devices.

Qualifications

• Bachelor’s degree in Engineering, or related science.
• 2–5 years in equipment validation or qualification (medical devices preferred).
• Familiarity with GxP/GMP requirements and FDA expectations.
• Experience with IQ/OQ/PQ protocols and execution.
• Strong SOP and protocol writing skills; ability to produce traceable, audit-ready records.
• Communication: Bilingual (English/Spanish).
• Full-time on-site; flexible to work occasional weekends or extra hours as needed.

Responsibilities

• Hands-on execution of installation, operational and performance qualification activities.
• Perform equipment risk assessments and support change control activities.
• Support equipment commissioning and handover to operations.

Skills

Bilingual English/Spanish

Education

Bachelor’s degree in Engineering or related science

Job description

Validation & Engineering Group, Inc. seeks a dedicated Equipment Validation Specialist to lead hands-on IQ/OQ/PQ execution and qualification activities.

The role requires performing risk assessments and supporting change controls, plus assisting in commissioning and handover to operations. Ideal candidates hold a Bachelor’s in Engineering or related science and have 2–5 years in equipment validation, preferably with medical devices.