Laboratory Validation Specialist

Job Title: Validation / Testing Analyst II (Laboratory Systems Validation Specialist)

Duration: 12 Months (1 Year Initial Contract)

Work Location: North Chicago, IL 60064 (100% Onsite)

Schedule: Monday – Friday (Standard Business Hours)

Travel Required: No

Position Purpose

The Laboratory Systems Validation Specialist is responsible for creating, configuring, testing, and validating custom calculations within Waters Empower and SampleManager LIMS.

In this role, you will develop and execute verification and validation (CSV) protocols, investigate discrepancies, route documentation through quality management systems (e.g., OneTrack), and interface directly with QC laboratory personnel, system owners, and Quality Assurance to ensure all computerized systems strictly comply with GMP and Good Documentation Practices (GDP).

Key Responsibilities:

Custom Calculations & Configuration:

• Design, configure, test, and validate complex custom calculations in Waters Empower to streamline chromatographic testing and laboratory data evaluation.
• Build, configure, and validate custom calculations, workflows, and templates in SampleManager LIMS.

Validation Lifecycle & Documentation:

• Draft, execute, and route verification and validation protocols, test scripts, and summary reports through electronic Quality Management Systems (e.g., OneTrack).
• Ensure full compliance with Computerized System Validation (CSV) guidelines, 21 CFR Part 11, data integrity principles, and Good Documentation Practices (GDP).

Discrepancy & Deviation Handling:

• Thoroughly investigate, troubleshoot, and document system discrepancies, test deviations, or unexpected results encountered during testing cycles.

Cross-Functional Collaboration:

• Partner closely with Quality Control (QC) analysts, system administrators, and QA teams to translate laboratory requirements into robust system specifications.
• Manage multiple deliverable timelines efficiently to hit targeted validation deadlines in a fast-paced environment.

Required Qualifications & Technical Skills:

• Education: Bachelor’s degree in Chemistry, Biology, Information Technology, Computer Science, or a related scientific/technical discipline.
• Experience: 3–5 years of hands-on experience supporting laboratory computerized systems, CSV (Computerized System Validation), or QC laboratory operations within a regulated life sciences / pharma / biotech environment.

Core Technical Expertise:

• Proven, hands-on experience configuring and validating custom calculations in Waters Empower (CDS).
• Proven, hands-on experience configuring and validating custom calculations/data handling in SampleManager LIMS.
• Regulatory Compliance: Strong working knowledge of GMP, GAMP 5 principles, 21 CFR Part 11, and Good Documentation Practices (GDP).
• Communication & Delivery: Excellent technical writing and verbal communication skills; demonstrated ability to work independently, manage deliverables, and collaborate with laboratory end-users.

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