Validation Engineer

Job Responsibilities Perform qualification ofQC laboratory equipmentin accordance withestablishedequipment qualificationpolicies, plans, andprocedures.Coordinate with laboratorypersonnel to defineequipment qualificationrequirements and acceptancecriteria.Author, review, andexecute equipment qualificationprotocols and relateddocumentation.Coordinate equipment qualificationactivities with equipmentvendors and internalsupport organizations.Ensure qualification activitiesare performed incompliance with currentcGMP regulations andapplicable quality standards.Review qualification documentationfor accuracy, completeness, and compliance.Identify business,quality, operational, andcompliance gaps associatedwith laboratory equipmentand qualification activities.Support resolution ofqualification-related issuesand coordinate appropriatecorrective actions.Maintain accurate andtimely validation andqualification records.Signand approve documentationfor activities withinauthorized responsibilitiesand applicable companyprocedures.Work closely withQC laboratory personneland cross-functionalstakeholders toensure equipment isqualified and readyfor intended use.Support continuous improvementinitiatives that enhancelaboratory compliance,operational efficiency,and cost effectiveness.Assist with schedulingand prioritizing qualificationactivities to meetbusiness objectives.Communicate qualificationstatus, issues, risks, and required actionsto appropriate stakeholders.Provide technical andoperational support toQC laboratory activitiesas assigned.Perform additional validation, qualification, and laboratorysupport duties asrequested by management. Skills cGMP RegulationsEquipment QualificationEquipment ValidationQC Laboratory ValidationValidation ProtocolsQualification Protocol AuthoringProtocol ExecutionValidation DocumentationPharmaceutical / BiopharmaceuticalManufacturingQuality ComplianceGMP DocumentationQuality SystemsCompliance Gap IdentificationContinuous ImprovementLaboratory EquipmentVendor CoordinationCross-Functional CollaborationTechnical DocumentationProblem SolvingProject CoordinationScheduling and PrioritizationVerbal and WrittenCommunication Education/Experience Bachelor's degree (BS/BA), preferably ina relevant scientificdiscipline.Experience in thepharmaceutical or biopharmaceuticalindustry, or anequivalentcombination of educationand experience.Knowledge of currentcGMP regulations orequivalent applicable regulations.Minimum 2 yearsof experience invalidation or equipmentqualification is desired.Experience supporting QClaboratory equipment qualificationactivities preferred.Ability to author, review, execute, andmaintain equipment qualificationdocumentation.Strong understanding ofquality and compliancerequirements in aregulated laboratory environment.Ability to makesound decisions regardingscheduling, priorities, and qualification activities.Flexible approach toproblem-solving andability to providedirection when required.Strong verbal andwritten communication skillswith the abilityto effectively influencestakeholders at differentorganizational levels.Ability tobuild trust-basedand effective workingrelationships with laboratorypersonnel, vendors, andcross-functional teams.Strategic thinking withthe ability totranslate objectives intoactionable plans.Strong ownership, accountability, and results-orientedapproach. #J-18808-Ljbffr SGS Consulting