Validation Engineer

Description

• Develop, maintain, or review validation and compliance documentation, including schematics, protocols, and engineering change notices.
• Collaborate and coordinate with departments and staff regarding scheduling or implementation of validation testing.
• Develop test methods, generate and maintain design specifications, and support product delivery teams in CAPA implementation and ECR/ECO activities.
• Consult with management and evaluate customer requirements to select validation objectives and standards.
• Work with scientists and engineers to assess and develop design and manufacturing specifications.
• Identify nonconformities of product or process standards and offer recommendations for resolving deviations.
• Analyze data from validation tests using statistical tools to determine whether results meet required criteria and specifications.
• Assist in investigations of test anomalies and validation failures.
• Use databases for tracking test results, validation activities, or validated systems.
• Conducting testing and analysis to validate robustness.
• Maintain technical records within design history files associated with assigned products.
• Prepare clear, compliant test protocols for validation or performance testing of products, equipment, processes, or systems.
• Frequently designs new tests and adapts existing ones.
• Modify testing methods and revisit test objectives and standards to resolve testing problems.
• Maintain accurate sample inventory, status, and study tracking within lab systems.

Requirements

• Hands-on mechanical design experience, including designing and building components that experience stresses.
• 2-5 years of experience in validation, quality, or laboratory testing in a regulated industry.
• Experience with physical product design and manufacturing processes, such as plastics, elastomers, metals, molding, and extrusion.
• Understanding failure modes and mitigating risks through design.
• Excellent interpersonal skills.
• Experience with Minitab or other statistical software is a plus.
• Thorough understanding of applicable mathematics, statistical, and scientific practices.
• Experience with benchtop electrical wiring is a plus.
• Bachelor’s degree in science, engineering, biology, or related technical field.
• Coding experience, preferably in Python, is a plus.
• Mechanical testing experience, including pressure, flow, tensile, leak, compression set testing, thermal and gamma effects, aging studies, and sensor setup for physical tests.
• Thorough understanding of industry standards and regulatory guidelines, such as cGMP and FDA.
• Thorough understanding of related equipment and the ability to perform equipment modifications.
• Proficient with Microsoft Office Suite or related software.
• Excellent verbal and written communication skills.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance