Validation Engineer/Equipment Validation Engineer

Key Responsibilities

• Execute and support IQ, OQ, and PQ validation activities for manufacturing equipment.
• Develop, review, and approve validation protocols and reports.
• Support process validation and equipment qualification activities.
• Work closely with Manufacturing, Quality, Engineering, and Operations teams.
• Ensure compliance with FDA regulations and ISO 13485 requirements.
• Perform risk assessments, gap analyses, and validation impact assessments.
• Review URS, FAT/SAT, SOPs, calibration, and maintenance documentation.
• Investigate deviations, non-conformances, and implement corrective actions.
• Support change control activities and continuous improvement projects.
• Assist during internal, customer, and regulatory audits.

Required Qualifications

• Bachelor's Degree in Engineering or related field.
• 5+ years of Validation, Quality, or Manufacturing Engineering experience.
• Strong experience with IQ/OQ/PQ execution.
• Experience in Medical Device Manufacturing.
• Knowledge of ISO 13485 and FDA-regulated environments.
• Experience supporting manufacturing operations.

Preferred Qualifications

• Experience with Additive Manufacturing / 3D Printing (Metal or Plastic).
• Titanium 3D Printing experience is highly preferred.
• Knowledge of process validation and equipment qualification.