CSV Engineer

Title : CSV Engineer Location: Indianapolis, IN Employment Type: Contract W2 Duration: 12 Months Industry: Pharmaceutical / Life Sciences About the Role We are seeking a Computer System Validation (CSV) professional to support validation activities for pharmaceutical computer systems and analytical laboratory equipment. The role focuses on software lifecycle management, equipment qualification, change controls, and regulatory compliance in a GxP-regulated environment. Responsibilities Execute CSV activities in accordance with GxP requirements, applicable regulations, and internal SOPs. Support software validation for new implementations, system updates, releases, and packaging-related changes. Manage and support change controls using TrackWise in collaboration with cross-functional teams. Use Kneat to document validation activities and maintain audit-ready records. Support onsite configuration, setup, and qualification of analytical laboratory equipment. Prepare and maintain validation documentation, including risk assessments, requirements, protocols, and reports. Lead or support qualification activities for analytical laboratory equipment, including LC, mass spectrometry, GC, UPLC, ICP systems, and pH meters. Ensure validation documentation and system lifecycle records remain accurate and compliant. Required Qualifications Hands-on experience in Computer System Validation within a pharmaceutical or GxP-regulated environment. Experience with analytical laboratory equipment qualification, such as LC, mass spectrometry, GC, UPLC, ICP, or pH meters. Knowledge of software lifecycle management, validation protocols, and release changes. Experience with change control processes and TrackWise. Familiarity with Kneat for validation documentation. Understanding of GxP compliance and audit-ready documentation practices. Ability to work onsite in Indianapolis, IN. Salary The hourly rate for this position is $45-49hr on W2 , depending on experience and qualifications. Benefits Eligible employees may have access to benefits in accordance with the applicable benefit plans and eligibility requirements. Equal Opportunity Employer We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Background Check Background checks may be conducted in accordance with applicable law. Work Authorization Applicants must be authorized to work in the United States. #J-18808-Ljbffr Intellectt INC