CSV Engineer
Occupations:
Validation EngineersComputer Systems Engineers/ArchitectsComputer Systems AnalystsSoftware DevelopersQuality Control Systems ManagersIndustries:
Other Professional, Scientific, and Technical ServicesEducational Support ServicesBusiness Schools and Computer and Management TrainingSupport Activities for Animal ProductionAdministration of Environmental Quality ProgramsJob DescriptionWe are seeking an experienced Computer Systems Validation (CSV) Engineer with strong communication skills and a true consultant mindset. The ideal candidate will have solid experience in pharma validation environments and hands-on exposure to manufacturing and automation systems.Requirements Bachelor's degree in computer science, Engineering, Life Sciences, or related field. 5+ years of experience in CSV/CSA frameworks (GAMP) within the Pharma industry. Hands-on experience with SCADA, OSI-PI, Siemens_desigo, Rockwell FactoryTalk Pharma Suite, DeltaV, and MES. Experience with system administration and EBR recipe authoring preferred. Strong understanding of ISA-95 model (Level 2 & Level 3 required; Level 1 is a plus). Knowledge of FDA regulations (21 CFR Part 11), Annex 11, EU GMP Annex 1, GxP practices, and Data Integrity principles. Experience performing system and data integrity risk assessments.