CSV Validation engineer

Role DescriptionThis is a Contract, on-site role for a CSV (Computer System Validation) Validation Engineer located in Indianapolis, IN. The CSV Validation Engineer will be responsible for the validation of systems (Delta V DCS, Wonderware SCADA and other Automation equipment) to ensure compliance with regulatory standards and company protocols. Daily responsibilities include writing and reviewing validation protocols, performing risk assessments, conducting validation tests, creating reports, and collaborating with cross-functional teams to meet project requirements. The role also involves supporting new system implementations and ensuring continuous compliance with Good Automated Manufacturing Practice (GAMP) guidelines.QualificationsStrong understanding of Computer System Validation (CSV) principles, regulations, and methodologiesExperience with Good Automated Manufacturing Practice (GAMP) and guidance from regulatory agencies such as FDA and EMAProficiency in writing and reviewing validation protocols, such as IQ, OQ, and PQFamiliarity with risk assessment tools and best practices to ensure compliance and mitigate potential system issuesStrong technical and analytical skills, with knowledge of software development life cycles and system implementation methodologiesEffective communication and teamwork abilities to collaborate with cross-functional teamsPrior experience in the life sciences or pharmaceutical industry is preferredBachelor's degree in Engineering, Computer Science, Life Science, or related field