CSV ENGINEER

Job Title: CSV Validation Specialist 📅 Experience: 5+ Years Overview We are seeking an experienced CSV Validation Specialist to support validation and qualification activities for infrastructure and regulated systems within a GxP environment. The ideal candidate will have strong expertise in computer system validation, infrastructure qualification, and regulatory compliance, along with the ability to lead validation efforts and collaborate with cross-functional teams. Key Responsibilities • Lead and execute Computer System Validation (CSV) activities across infrastructure and application systems • Perform infrastructure qualification for systems such as Okta, Active Directory, AWS, and dedicated computing environments • Develop, review, and execute validation lifecycle documentation including URS, FS/DS, Risk Assessments, IQ/OQ/PQ, and Validation Summary Reports • Validate systems such as RStudio/Posit, Pinnacle 21, SAS, and similar platforms • Work with Veeva Vault Quality for validation management, test script authoring, and execution • Support deviations, investigations, change control, and CAPA processes • Ensure compliance with GxP, 21 CFR Part 11, and GAMP 5 guidelines • Conduct risk assessments (FMEA) and ensure data integrity (ALCOA+) principles are followed • Collaborate with cross-functional teams including QA, IT, Engineering, and Business stakeholders • Support audit readiness and regulatory inspections (FDA, EMA) • Provide leadership, guidance, and mentorship to junior team members when needed Required Qualifications • Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field • 5+ years of experience in CSV within regulated (Pharma/Medical Device) environments • Strong experience in infrastructure validation and qualification • Hands-on experience with validation of applications and cloud-based systems • Experience with Veeva Vault Quality (Validation Management module preferred) • Strong knowledge of Deviations, CAPA, Change Control processes • Excellent documentation, communication, and project management skills Preferred / Nice to Have Skills • Experience with cloud platforms (AWS) and modern validation approaches • Knowledge of data integrity principles (ALCOA+) • Experience in audit support and regulatory inspections • Familiarity with statistical tools and validation methodologies • Ability to work in a fast-paced, cross-functional environment