EXPANSION Validation Specialist

Expansion Validation SpecialistBusiness: Pharma Solutions Department: Validation Location: LexingtonJob OverviewReporting to the Validation Supervisor, the Validation Specialist executes validation and qualification protocols of manufacturing, packaging, laboratory, utility systems and other equipment, in accordance with current Good Manufacturing Practices (cGMPs), Good Engineering Practices (GEP) and change control.Reporting StructureThis position reports to the Validation Supervisor.Key Responsibilities:Write, schedule, plan, manage and execute validation and qualification protocolsAct as technical interface between the company and 3rd parties for discussions surrounding the on-site validation activitiesCoordinate and interface with Operations, Technical Services, Facility Engineering, Microbiology, and Quality Assurance groups to ensure successful project executionLead qualification activities and timelines for equipment purchased for manufacturing purposesCoordinate order timelines and equipment requirements with Technical Services group.Represent validation at project team meetings and provide expert validation advice.Independently design, plan and manage own studies.Manage the development of the following documents for new equipment:User requirement specification (URS)Design qualification (DQ)Commissioning (CX)Risk assessment (RA)Maintain and develop state of the art knowledge regarding existing and future validation processes and maintain up-to-date knowledge on regulatory expectationsLead investigations related to validation discrepancies and ensure thoroughness of investigation, documentation and closure.Implement preventive/corrective actions as necessaryConduct periodic validation reviews of equipment, facilities, utilities, and sterilization cyclesAuthor assigned Standard Operating Procedures (SOPs) for Validation departmentQualifications:Bachelor's Degree in the physical or biological sciences or engineering preferred.2+ years of QA and/or Regulatory experience in a cGMP/FDA regulated environmentSterile manufacturing of injectables strongly preferredThorough knowledge of cGMP (Current Good Manufacturing Practice) regulations, guidance, and general compliance expectations.Technical writing skillsIn-depth understanding of investigational techniques, including but not limited to root cause analysis, risk assessment, impact evaluation, and technical report writingWorking knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP)Thorough understanding of Common Technical Document (primarily Chemistry and Manufacturing Controls (CMC) format, content, and filing requirements for US and EU.High level of proficiency operating all Microsoft Office applicationsExcellent communication skills, both verbally and in writingDetail oriented and organized