Equipment Validation Specialist

Position Overview
Weil Group is seeking a Laboratory Equipment Validation Specialist to support the qualification and validation of Quality Control (QC) laboratory instrumentation, with primary responsibility for the Thermo Scientific™ Nicolet™ FTIR system. The specialist will execute the full validation lifecycle—including IQ, OQ, and PQ—ensuring compliance with regulatory requirements, internal procedures, and Good Documentation Practices (GDP). This role directly supports QC operations by ensuring the FTIR system is validated, compliant, and ready for routine analytical use.

Key Responsibilities
Equipment Validation & Qualification

• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for FTIR instrumentation.
• Develop, execute, and document validation protocols (Validation Plan, IQ/OQ/PQ, Final Report).
• Ensure FTIR validation complies with 21 CFR Part 11, ALCOA+, and QC analytical standards.
• Perform calibration verification, system suitability tests, and requalification activities as required.

Technical & Compliance Activities

• Coordinate calibration and preventive maintenance with Thermo Fisher Scientific or approved vendors.
• Verify proper system configuration, spectral libraries, accessories, and software installation (e.g., OMNIC™, OMNIC Anywhere).
• Support troubleshooting during qualification and collaborate with QC, Engineering, IT, and Metrology.
• Assist with method transfer or analytical verification activities related to FTIR use.

Documentation & GDP

• Document all validation activities accurately and in compliance with cGMP and GDP.
• Maintain validation files, change controls, deviations, traceability matrices, and supporting evidence.
• Ensure all records are audit-ready and aligned with internal and regulatory expectations.

Cross-Functional Collaboration

• Work closely with QC analysts, QA, Engineering, and vendors during validation execution.
• Provide validation documentation and support during internal/external audits.
• Communicate progress, issues, and deliverables effectively to project stakeholders.

Required Qualifications

• Bachelor’s degree in Chemistry, Engineering, Biotechnology, Pharmaceutical Sciences, or related scientific field.
• 1–4 years of experience in laboratory equipment validation or QC instrumentation support.
• Hands-on experience operating or validating FTIR spectroscopy systems; experience with Thermo Scientific Nicolet is highly preferred.
• Strong understanding of IQ/OQ/PQ, cGMP, GDP, and 21 CFR Part 11 requirements.
• Excellent attention to detail and strong technical writing skills.

Preferred Qualifications

• Experience validating additional QC analytical instruments (HPLC, GC, UV-Vis, pH meters, stability chambers, etc.).
• Familiarity with spectroscopy techniques such as NIR, Raman, or IR microscopy.
• Experience working with Thermo Fisher data systems or equivalent laboratory software.
• Ability to work independently, manage multiple assignments, and support fast-paced QC operations.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*