Validation Engineer (Medical Devices Industry)

ProQuality Network; United States; Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Job summary

ProQuality Network is seeking a Validation Engineer - Process Development in Puerto Rico to drive IQ/OQ/PQ activities, develop Master Validation Plans, and author validation protocols in a regulated medical devices environment.

The role partners with Process Development, Quality, Engineering, and Regulatory teams to ensure compliant validation, robust documentation, and continuous improvement, while supporting cross-functional product and process innovations.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 3–5 years of experience in process or equipment validation in a regulated industry (medical devices preferred).
• Strong understanding of IQ/OQ/PQ, validation lifecycle, and cGMP principles.
• Experience developing validation protocols, technical reports, and Master Validation Plans.

Responsibilities

• Support process and/or equipment validation activities (IQ, OQ, PQ), including PPQ and Master Validation Plans.
• Develop, review, and approve validation protocols, reports, and related documentation.
• Collaborate with Process Development to qualify new processes, including sampling plans and procedures.
• Design and implement in-process and receiving quality systems for new processes and components.
• Prepare and maintain equipment documentation, including entries, evaluations, PMs, and calibration procedures.
• Define appropriate gauges, tools, and equipment for test method development.
• Generate manufacturing instructions and process documentation for new production lines.
• Partner with cross-functional teams (Quality, Engineering, Manufacturing, Regulatory) to achieve process development goals.

Skills

Process validation

IQ/OQ/PQ

cGMP principles

Documentation

Education

Bachelor’s degree in Engineering

Job description

Validation Engineer (Medical Devices Industry)

Title: Validation Engineer (Medical Devices Industry)

Location : North of Puerto Rico (Open for residents of Puerto Rico that are U.S. Citizens)

Summary

Our client, a leading organization in the medical device sector, is seeking a Validation Engineer - Process Development to support process and equipment validation initiatives within the engineering and manufacturing environments. This professional will be responsible for developing, executing, and reviewing validation documentation, ensuring all processes meet quality and regulatory standards. The ideal candidate will bring strong technical skills, hands-on validation experience, and the ability to work cross-functionally to support process innovation and continuous improvement.

Key Responsibilities

• Support process and/or equipment validation activities (IQ, OQ, PQ), including Process Performance Qualification (PPQ) and the development of Master Validation Plans for new products or processes.
• Develop, review, and approve validation protocols, reports, and related documentation in accordance with internal procedures and regulatory guidelines.
• Collaborate with the Process Development team to qualify new processes, including assistance with statistical sampling plans and development procedures.
• Design and implement in-process and receiving quality systems for new processes and components.
• Prepare and maintain equipment documentation, including entries, evaluations, PMs, and calibration procedures.
• Define appropriate gages, tools, and equipment required for test method development.
• Generate manufacturing instructions and process documentation for new production lines.
• Partner with cross-functional teams (Quality, Engineering, Manufacturing, Regulatory) to achieve process development goals.

Quality System Responsibilities

• Demonstrate a commitment to patient safety and product quality by adhering to the company’s Quality Policy and all documented quality system procedures.
• Ensure adequate resources, tools, and personnel are in place to maintain Quality System compliance.
• Promote a culture of quality and continuous improvement, ensuring compliance with applicable regulatory and internal requirements.

Summary of Qualifications

• Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field).
• Minimum of 3-5 years of experience in process or equipment validation within a regulated industry (medical devices, pharma, or biotech preferred).
• Strong understanding of IQ/OQ/PQ, validation lifecycle, and cGMP principles.
• Experience developing and executing validation protocols, technical reports, and Master Validation Plans.
• Familiarity with statistical analysis, sampling plans, and risk management tools (FMEA, PFMEA, etc.).
• Excellent communication, organization, and documentation skills.
• Ability to work collaboratively in a cross-functional and fast-paced environment.