Master Compliance | Senior Validation Engineer

Job Title: Senior Validation EngineerStart Date: ImmediateDuration: 6 months plus ExtensionsWork Location: Boston, MA (100% Onsite)Job OverviewWe are looking for an experienced Senior Validation Engineer - flexible working 100% Onsite. This role requires hands-on expertise in sterile and cleaning validation processes, excellent technical writing abilities, and the capacity to execute validation protocols independently.Key ResponsibilitiesDevelop and implement sterile and cleaning validation protocols (IQ, OQ, PQ, CVP) in compliance with FDA, ISO 13485, and GMP standards.Perform risk assessments and conduct gap analyses to ensure adherence to validation requirements.Execute validation activities for autoclaves, cleanrooms, sterilization methods (EtO, gamma, steam), and CIPSIP systems.Oversee cleaning validation processes, including residue testing, recovery studies, and establishing acceptance criteria.Author technical reports, validation master plans (VMPs), and comprehensive summary reports.Support FDA inspections and audits by providing expertise on validation activities.Identify opportunities for process optimization and address validation deviations effectively.Required QualificationsOver 10 years of expertise in sterile and cleaning validation within the medical device, biotech, and pharmaceutical prehensive knowledge of FDA regulations, ISO 13485, 21 CFR Part 820, EU MDR, and GMP compliance standards.Demonstrated proficiency in sterilization validation methods, including gamma, steam, and dry heat. Hands-on experience in cleaning validation, and strategies for bioburden reduction.Exceptional skill in authoring and reviewing validation documentation with a high level of technical accuracy.Proficient in using advanced validation software such as Kaye Validator.Experienced with QMS platforms, including MasterControl, for effective quality management.

Created: 2025-01-20