Equipment Validation Specialist, Level III

Role & Responsibilities Ensure critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and regulatory guidelines. Perform Equipment Validation Maintenance, re-qualification, and change control assessments to verify ongoing validation status. Develop validation protocols from plans and engineering documents, review and approve SOPs, protocols, deviations, and change controls. Program, organize, and train personnel on validation equipment and supplies. Contribute to Quality Systems activities such as Document Management, Laboratory Information Management System (LIMS), and Trackwise. Qualifications & Skills Preferred bachelor’s degree or equivalent industry experience.Minimum of 2+ years in manufacturing processes, QC, or environmental monitoring.Strong technical writing, documentation, and root cause analysis skills.Experience with Quality Systems including DMS, LIMS, and Trackwise.Ability to prioritize tasks, work independently, and demonstrate strong organizational skills. Key Attributes: Knowledge of biopharmaceutical equipment validation (IQ, SIP, autoclaves, clean utilities, storage temperature mapping), meticulous documentation, and compliance with regulatory standards. The role involves on-site work and collaboration with cross-functional teams to support a compliant manufacturing environment.