Csv Specialist
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The selected candidate will support the validation lifecycle of systems such asSiemens Desigo CC, ensuring compliance withFDA regulations, GAMP 5 methodologies, Data Integrity requirements, and site quality procedures .
Key Responsibilities
Develop and executeIQ, OQ, and PQ protocols .
Author and review validation documents, including:Validation PlansURSRisk AssessmentsTraceability MatricesValidation Summary Reports (VSR)Validate BAS/BMS and HVAC systems, including alarms, trends, controllers, sensors, and field devices.
Support change controls, deviations, discrepancies, and CAPA activities.
Verify compliance with21 CFR Parts 11, 210, and 211, GAMP 5, and Data Integrity requirements.
Collaborate with Engineering, Facilities, Automation, Validation, and Quality teams.
Support regulatory inspections and audit readiness activities.
Minimum QualificationsBachelor's Degree in Engineering, Life Sciences, or related discipline.3+ years of experience inValidation, Commissioning & Qualification (C&Q), Automation, or CSVwithin a GMP-regulated environment.
Experience executingIQ/OQ/PQ protocols .
Knowledge of:Building Automation Systems (BAS/BMS)HVAC SystemsGAMP 5FDA RegulationsData Integrity PrinciplesStrong technical writing and documentation skills.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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