Test Method Validation Engineer

Analytical Test Method Validation Engineer

Location: Fitchburg, WI – Onsite

Contract: 6 month duration with potential for extensions

Position Overview:

Our client is seeking a Test Method Validation Engineer to support validation activities for analytical and functional test methods used in the manufacture of life-science reagents and in-vitro diagnostic (IVD) products. The role will focus on designing and executing method validation and transfer protocols in compliance with cGMP, ISO 13485, and FDA/IVDR requirements. This is a 6-month contract position located on-site in Middleton, WI.

Key Responsibilities:

• Develop and execute validation protocols (IQ/OQ/PQ or method validation) for analytical, microbiological, and functional test methods used in product release and stability testing.

• Collaborate with Quality Control, Manufacturing, and R&D to ensure methods are fit-for-purpose and compliant with regulatory and internal quality system requirements.

• Perform method robustness, precision, accuracy, linearity, range, and specificity studies following ICH Q2(R2), USP <1225>, and related standards.

• Lead or support method transfers between development and QC laboratories, ensuring full documentation and training deliverables.

• Review and approve validation protocols, raw data, and final reports, ensuring traceability and data integrity.

• Participate in risk assessments and support deviation, CAPA, and change control activities related to analytical methods.

• Maintain validation documentation in compliance with ISO 9001 / 13485 and FDA 21 CFR Part 11 expectations.

• Provide technical input to continuous improvement of test method lifecycle management processes.

Education, Experience & Skill Qualifications:

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Molecular Biology, or related scientific discipline.
• Minimum 3–5 years of experience in a regulated (GMP/GLP/ISO 13485) biotechnology, diagnostics, or pharmaceutical laboratory environment.
• Strong understanding of method validation and transfer requirements under FDA/IVD and ICH guidelines.
• Hands-on experience with qPCR, HPLC, spectrophotometry, ELISA, enzyme assays, and DNA quantitation methods preferred.
• Proficiency in statistical data analysis for validation (e.g., ANOVA, regression, variance components).
• Excellent documentation, technical writing, and communication skills.
• Familiarity with reagent manufacturing environments (lyophilized reagents, nucleic acid extraction kits, luminescent detection systems) is a plus.