The posting
Position Summary The Sanitation Validation Coordinator is responsible for coordinating, documenting, and supporting sanitation and cleaning validation activities to ensure manufacturing equipment, production areas, utilities, and sanitation processes comply with current Good Manufacturing Practices (cGMP), company policies, customer requirements, and applicable regulatory standards. This position works closely with Quality, Production, Sanitation, Facilities, and Regulatory teams to support validation studies, maintain required documentation, coordinate execution activities, and ensure sanitation programs are effectively implemented and sustained. Essential Duties and Responsibilities
Coordinate sanitation and cleaning validation activities throughout manufacturing operations. Assist in the development, maintenance, and tracking of sanitation validation plans and schedules. Prepare, revise, distribute, and maintain validation protocols, reports, forms, logs, and supporting documentation. Coordinate the execution of sanitation and cleaning validation studies with cross-functional departments. Collect, organize, review, and maintain validation data for accuracy and completeness. Support environmental monitoring, swab sampling, rinse sampling, and laboratory testing activities as required. Track validation activities, completion dates, deviations, CAPAs, and action items. Maintain validation files, databases, master logs, and controlled documentation. Ensure all validation documentation meets internal quality standards and regulatory requirements. Assist with investigations related to sanitation failures, validation exceptions, and non-conformance events. Prepare validation summaries, reports, and trend analyses for management review. Support internal audits, customer audits, and regulatory inspections by providing required documentation and records. Collaborate with Quality, Production, Facilities, Engineering, and Regulatory teams to support compliance initiatives. Recommend process improvements to enhance sanitation effectiveness and validation compliance. Follow all safety policies, SOPs, GMP requirements, and company procedures. Perform additional duties as assigned.
Qualifications Education
High School Diploma or equivalent required. Associate's or Bachelor's degree in Biology, Chemistry, Food Science, Quality, Engineering, Life Sciences, or related discipline preferred.
Experience
2 to 4 years of experience in quality, sanitation, validation, manufacturing, laboratory, or regulatory environments preferred. Experience in cosmetics, personal care, pharmaceutical, food, or other regulated manufacturing environments preferred. Experience with document control and compliance-based recordkeeping preferred. Experience supporting audits and inspections is a plus.
Knowledge, Skills, and Abilities
Knowledge of cGMP requirements and sanitation practices. Familiarity with cleaning validation and environmental monitoring programs. Strong organizational and project coordination skills. Excellent written and verbal communication skills. Strong attention to detail and documentation accuracy. Ability to manage multiple priorities and deadlines. Proficiency in Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint. Ability to analyze data and generate reports. Strong problem-solving and follow-up skills. Ability to work independently and collaboratively in a cross-functional environment.
Physical Requirements
Ability to lift up to 25 pounds. Ability to stand, walk, bend, and sit for extended periods. Ability to work in both manufacturing and office environments. Ability to wear required personal protective equipment (PPE).
Work Environment
Combination of office and manufacturing environments. Exposure to production, sanitation, and laboratory areas. Moderate noise levels. Frequent interaction with production, quality, engineering, and sanitation personnel.
