Validation Engineer

*Position Summary* The *Equipment & Utilities Validation Engineer* is responsible for planning, executing, and documenting validation activities for critical systems in a cosmetics and personal care manufacturing facility. This includes compounding vessels, filling lines, HVAC systems, and purified water utilities. The role ensures compliance with GMP, FDA cosmetic/OTC regulations, and ISO standards, supporting safe, high‑quality product manufacturing. *Key Responsibilities* * *Equipment Qualification* Develop and execute IQ/OQ/PQ protocols for mixers, pumps, filling lines, and packaging equipment. * *Facilities Validation* Validate cleanrooms, controlled environments, and HVAC systems to ensure compliance with cosmetic GMP standards. * *Water & Utility Systems* Conduct validation of purified water, WFI, compressed air, and steam systems to meet microbial and chemical specifications. * *Documentation & Compliance* Prepare validation protocols, reports, and change control documentation in line with FDA 21 CFR Part 11, ISO 22716, and EU Annex 15. * *Audit Readiness* Maintain complete validation records and support regulatory inspections and customer audits. * *Risk & Impact Assessments* Perform risk assessments to identify critical systems impacting product quality and consumer safety. * *Cross‑Functional Collaboration* Partner with Quality, Production, and Engineering teams to resolve validation issues and implement corrective/preventive actions. *Qualifications* * Bachelor’s degree in Engineering, Chemistry, Microbiology, or related field. * 3+ years of validation experience in cosmetics, personal care, pharmaceutical, or food manufacturing. * Strong knowledge of GMP, FDA cosmetic/OTC regulations, ISO 22716, and validation lifecycle. * Experience with utilities (water, HVAC, compressed air) and equipment qualification. * Excellent technical writing, documentation, and data analysis skills. *Competencies* * *GMP Compliance* * *Validation Lifecycle* * *Risk Assessment* * *Technical Documentation* * *Audit Preparation* Pay: $85,000.00 - $95,000.00 per year Benefits: * 401(k) * Dental insurance * Health insurance * Paid time off * Vision insurance Work Location: In person