Validation Engineer

QRC Group; Caguas (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

QRC Group in Caguas, Puerto Rico is seeking a Validation Engineer to support equipment validation activities in a medical device manufacturing environment (21 CFR Part 820 / ISO 13485). Focus on protocol execution, troubleshooting, and direct coordination with the client's team and equipment vendors.

The candidate will develop IQ/OQ/PQ protocols, perform deviations, and ensure compliance across the Validation Life Cycle.

Qualifications

• Bachelor's degree in Engineering required.
• Minimum 5 years validation experience in medical device/pharma.
• Hands-on IQ/OQ/PQ development and execution.
• Experience with cGMP and FDA 21 CFR Part 820.
• Strong written English skills (and Spanish).

Responsibilities

• Develop, execute, and close IQ/OQ/PQ protocols and reports.
• Troubleshoot equipment and drive issue resolution.
• Coordinate with client teams and vendors for support.
• Support full Validation Life Cycle including risk assessment and deviations.
• Assess validation impact of equipment changes and change control.

Skills

Troubleshooting

Technical writing

Bilingual EN/ES

Education

Bachelor's degree in Engineering

Job description

Caguas, Puerto Rico | Posted on 07/30/2026

We are seeking a Validation Engineer to support equipment validation activities in a medical device manufacturing environment (21 CFR Part 820 / ISO 13485). Hands-on role focused on protocol execution, technical troubleshooting, and direct coordination with the client's team and equipment vendors.

Responsibilities

• Develop, execute, and close IQ/OQ/PQ protocols and summary reports for manufacturing equipment and utilities.
• Troubleshoot equipment and execution issues, determine root cause, and drive resolution to closure.
• Work hand-in-hand with the client's engineering, quality, and manufacturing teams, and coordinate with equipment vendors/OEMs for technical support when required.
• Support the full Validation Life Cycle: planning, URS/FRS, risk assessment (FMEA), RTM, execution, deviations, and closure.
• Assess validation impact of equipment changes and support change control activities.

Requirements

• Bachelor's Degree in Engineering. Required — no equivalent substitutions.
• Minimum of five (5) years of validation experience in medical device or pharmaceutical manufacturing.
• Hands-on equipment validation experience (IQ/OQ/PQ development and execution).
• Proven troubleshooting capability, including direct interaction with vendors/OEMs.
• Working knowledge of the Validation Life Cycle, cGMP, and FDA 21 CFR Part 820.
• Strong technical writing skills. Fully bilingual (English/Spanish).
• Availability to support production schedules, including off-shift coverage as required.