Validation Engineer (Medical Device)

Key Responsibilities:

• Plan, execute, and manage validation activities for equipment, processes, and test methods.
• Maintain and update validation master lists and related documentation.
• Conduct stability and transportation studies as per customer requirements.
• Oversee and maintain testing equipment to ensure compliance and proper calibration.
• Manage customer change requests and update related quality documentation.
• Review and revise product and raw material specifications when necessary.
• Lead or support non-conformance investigations, including root cause analysis and corrective/preventive actions.
• Identify improvement opportunities through data analysis and risk assessments.
• Support internal, supplier, and external audits.
• Collaborate with cross-functional teams on new product introduction and continuous improvement projects.

Key Requirements:

• Bachelor's Degree in Science, Chemistry, or Chemical Engineering (or related field).
• Minimum 3 years' experience in a manufacturing or medical device environment.
• Familiar with ISO 13485, GMP, and FDA 21 CFR Part 820 standards.
• Experience working in a cleanroom setting is preferred.
• Strong analytical, problem-solving, and communication skills.
• Independent, proactive, and able to work effectively in a team.