Validation Engineer

Overview

About the Company. Growing company with multiple manufacturing locations has an exciting opportunity available for a Validation Engineer.

The Validation Engineer will collaborate with stakeholders at all company locations to conduct product, process and equipment validations, risk assessments, develop testing methods and various test/process validation requirements. This individual will support cross functional teams to ensure product or process verification supports all internal and product compliance requirements.

The Validation Engineer will collaborate with stakeholders at all company locations to conduct product, process and equipment validations, risk assessments, develop testing methods and various test/process validation requirements.

• Consult with management, evaluate customer requirements, and studies product characteristics to select validation objectives and standards.
• Prepare clear, compliant test protocols for validation or performance testing of new or existing products, equipment, processes, or systems.
• Analyze data from validation tests using statistical tools (DOE, capability analysis) to determine whether results meet required criteria and specifications.
• Maintain technical records within design history files associated with assigned products.
• Collaborate and coordinate with appropriate departments and staff regarding the scheduling or implementation of validation testing.
• Assist in investigations of test anomalies and validation failures.
• Identify nonconformities of product or process standard and offer recommendations for resolving deviations.
• Use databases for tracking test results, validation activities, or validated systems.
• Develop, maintain, or review validation and compliance documentation including schematics, protocols, and engineering change notices.
• Modify testing methods, revisit test objectives and standards to resolve testing problems.
• Develop test methods, generate, and maintain design specifications, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, etc.
• Support Product Delivery Teams (PDT), including creating and or reviewing quality documents, participating in CAPA implementation, and generating or supporting ECR (Engineering Change Request) & ECO (Engineering Change Order) activities.
• Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
• Maintain accurate sample inventory, status, and study tracking within lab systems.
• Perform other related duties as assigned.

• Bachelor’s degree in science, engineering, biology, or related technical field.

• 2-5 years of experience in validation, quality, or laboratory testing in a regulated industry.
• Excellent verbal and written communication skills.
• Excellent interpersonal skills.
• Thorough understanding of industry standards and regulatory guidelines (cGMP, FDA, etc.) preferred.
• Thorough understanding of applicable mathematics, statistical, and scientific practices.
• Thorough understanding of related equipment and the ability to perform equipment modifications.
• Proficient with Microsoft Office Suite or related software.
• Experience with Minitab or other statistical software a plus.
• Experience with benchtop electrical wiring a plus.

• Experience with Minitab or other statistical software a plus.
• Experience with benchtop electrical wiring a plus.

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