Validation Specialist Position Available In Johnston, North Carolina

Validation Specialist Job Description As a Validation Specialist, you will perform revalidation on equipment and processes according to approved timelines. You will support validation activities related to changes in existing and new systems, including formulation, sterilization, cleaning, filling, and inspection processes. Your role will involve authoring and reviewing documents to ensure compliance with local, corporate, and regulatory regulations, and collaborating on IQ, OQ, and PQ protocols. Responsibilities Perform and review revalidation activities. Work and communicate effectively across departments to schedule and perform revalidations. Author and review documents in accordance with local, corporate, and regulatory regulations. Collaborate and review IQ, OQ, and PQ protocols for systems and processes. Support and/or lead the closure of investigations using root cause analysis techniques. Participate in continuous improvement initiatives using cLEAN tools. Ensure executed protocol data is accurate and meets documented acceptance criteria. Manage Change Requests related to revalidation and other validation activities. Author and review validation procedures, specifications, and quality documents. Present and support validation concepts during audits and inspections. Follow all safety and environmental requirements. Essential Skills Experience in revalidation, validation, and GMP processes. Hands-on experience with production equipment including CIP Skids, autoclaves, depyrogenation tunnels, and washers. Strong data analysis, report generation, and document archival skills. Bachelor’s degree in Engineering, Computer Science, or a relevant scientific discipline. Minimum of two years of experience in validation processes within the pharmaceutical or medical device industry. Familiarity with technical documents related to validation efforts. Experience in quality concepts and technical compliance review of validation documents. Additional Skills & Qualifications Experience with autoclaves, depyrogenation tunnels, filling lines, or washers. Experience in cGMP documentation practices and regulations. Basic computer skills including Microsoft Word and Excel. Knowledge of statistical methods. Strong oral and written communication skills. Experience with validation test equipment like temperature mapping and data loggers. Experience in project team collaboration. Root cause analysis techniques experience. Work Environment The role involves supporting revalidation efforts for annual production equipment cycles, with a mix of hands-on work and reporting/data analysis. The position supports a large pharmaceutical manufacturing site with significant growth potential. The work environment encourages collaboration and provides opportunities for project work in a legacy manufacturing site.