Position Overview
The Validation Specialist ensures that all manufacturing processes, equipment, and products within the health and beauty industry meet regulatory, quality, and safety standards. This role is critical in maintaining compliance with GMP, FDA, and ISO requirements while supporting product integrity and consumer safety.
Key Responsibilities
Process Validation: Develop and execute validation protocols to confirm that compounding, filling, and packaging processes consistently meet specifications.
Equipment Qualification: Perform IQ/OQ/PQ testing for mixers, kettles, homogenizers, filling lines, and cleaning systems.
Cleaning Validation: Ensure sanitation procedures prevent cross-contamination between batches.
Documentation & Compliance: Maintain validation protocols, reports, and change control records in accordance with GMP and FDA/ISO standards.
Raw Material Validation: Verify that ingredients meet purity and performance requirements.
Stability & Shelf-Life Testing: Conduct studies to confirm products remain safe and effective over their intended shelf life.
Regulatory Support: Collaborate with QA/RA teams to prepare documentation for FDA, ISO, or EU cosmetic regulations.
Required Skills & Qualifications
Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.
3-5+ years of validation experience in cosmetics, personal care, or pharmaceutical manufacturing.
Strong knowledge of GMP, GLP, and ISO 22716 (Cosmetics GMP).
Experience designing and executing validation protocols (IQ/OQ/PQ).
Familiarity with FDA 21 CFR Part 11 and EU cosmetic regulations.
Excellent analytical, documentation, and report-writing skills.
Validation Specialist • Ottawa, IL, United States
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