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.

If you are a results-driven professional with hands-on validation expertise and a passion for quality and process improvement, we invite you to apply through the job description link with your updated resume to be considered for this exciting opportunity.