Validation Engineer

You will ensure compliance with medical device standards within the Production Engineering – Process Validation team.

Responsibilities

• Review process validations to identify gaps against internal and external requirements.
• Generate, execute, and report on Test Method Validation and Process Validation protocols.
• Collaborate with functional groups to identify process validation needs.
• Apply statistical, quality, and continuous improvement methods to validation workflows.

Required Skills

• 5+ years of experience in validation engineering.
• Knowledge of ISO 13485 and 21 CFR regulations.
• Understanding of ISO 14971 risk management standards.
• Proficiency in statistical and quality improvement tools.
• Experience with medical device regulation and best practices.
• Ability to manage protocol generation and report generation.

Education

• Graduate degree in any field.