Validation Engineer

Zohorecruit; Caguas (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Zohorecruit is seeking a Validation Engineer in Caguas, Puerto Rico to support equipment validation activities in a medical device manufacturing environment. The role centers on IQ/OQ/PQ protocol execution, troubleshooting, and coordination with the client’s engineering and vendor teams.

Requirements include a Bachelor’s in Engineering, 5+ years of validation experience, strong technical writing, and bilingual English/Spanish.

Qualifications

• 5+ years of validation experience in medical device/pharma manufacturing.
• Hands-on IQ/OQ/PQ development and execution.
• Experience troubleshooting with vendors/OEMs.
• Strong technical writing and bilingual English/Spanish.

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.
• Coordinate with client's engineering, quality, and manufacturing teams, and with vendors for technical support.
• Support the full Validation Life Cycle: planning, URS/FRS, risk assessment, RTM, execution, deviations, and closure.
• Assess validation impact of equipment changes and support change control activities.

Skills

Validation

Troubleshooting

Technical writing

Bilingual English/Spanish

Education

Bachelor's Degree in Engineering

Job description

Caguas, Puerto Rico | Posted on 09/24/2026

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.