Job Description

Job Description: Test Method Validation Engineer

Location: Round Lake, IL

Experience: 7+ years

We are seeking a highly skilled Test Method Validation Engineer to join our team in Round Lake, IL. The ideal candidate will have extensive experience in test method validation, with a strong background in ensuring the accuracy, reliability, and repeatability of testing procedures within a regulated industry.

Key Responsibilities:

• Develop and execute test method validation protocols and reports in accordance with regulatory requirements (e.g., FDA, ISO).
• Lead and coordinate validation activities for new and existing test methods used in product development and manufacturing.
• Design and implement statistical analysis methods to assess test method performance, including capability studies, measurement system analysis (MSA), and gauge R&R.
• Collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to define validation requirements and timelines.
• Identify and resolve issues related to test method performance and reliability through systematic investigation and troubleshooting.
• Ensure compliance with company standards, regulatory guidelines, and industry best practices throughout the validation process.
• Provide technical expertise and guidance on test method validation principles and methodologies.
• Participate in audits and inspections related to test method validation activities.

Required Skills and Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
• 7+ years of experience in test method validation within a regulated industry (e.g., medical devices, pharmaceuticals).
• Expertise in developing and executing validation protocols, reports, and associated documentation.
• Strong understanding of statistical methods and tools used in test method validation (e.g., Minitab, JMP).
• Knowledge of regulatory requirements and standards applicable to test method validation (e.g., FDA 21 CFR Part 820, ISO 13485).

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