Automated Systems,
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.
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
, 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.
Company Description: We are a dynamic, project‑oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.
#J-18808-Ljbffr
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.
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
, 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.
Company Description: We are a dynamic, project‑oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.
#J-18808-Ljbffr