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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