Validation Engineer

Job description

Validation Engineer – Medical Devices

📍 Location: United States (Onsite)
💼 Job Type: Full-Time
🏥 Industry: Medical Devices

Job Summary

We are seeking a detail-oriented Validation Engineer to develop, execute, and document validation activities for equipment, systems, processes, and software. The ideal candidate will ensure compliance with industry standards, regulatory requirements, and company quality policies.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ).
• Prepare validation plans, reports, and documentation.
• Validate manufacturing equipment, processes, and computer systems.
• Investigate validation failures and implement corrective actions.
• Collaborate with Quality Assurance, Manufacturing, Engineering, and Production teams.
• Ensure compliance with GMP, FDA, ISO, and other regulatory standards.
• Perform risk assessments and change control activities.
• Review and maintain validation records.
• Support internal and external audits.
• Recommend process improvements to enhance product quality and efficiency.

Required Skills

• Knowledge of IQ, OQ, PQ, and process validation.
• Understanding of GMP, GLP, FDA, and ISO regulations.
• Strong analytical and problem-solving skills.
• Experience with validation documentation.
• Good communication and teamwork abilities.
• Familiarity with CAPA, Change Control, and Risk Management.
• Proficiency in Microsoft Office and documentation tools.

Qualifications

• Master's degree in Mechanical, Electrical, Chemical, Biomedical, Industrial Engineering, or a related field.
• Master should be before 2025
• 1–5+ years of validation experience (depending on the role).
• Experience in pharmaceutical, medical device, biotechnology, semiconductor, or manufacturing industries is preferred.

Preferred Certifications

• ASQ Certified Quality Engineer (CQE)
• Six Sigma Green Belt/Black Belt (preferred)
• GMP or ISO training