Senior Computer System Validation Specialist

Job Title : Senior CSV/ CSA Specialist Department : Information Technology Location: Remote, East Coast Preferred Hours Per Week: 40 Schedule: Days, Monday – Friday SUMMARY The Senior CSV/CSA Specialist leads risk-based validation and assurance activities for GxP-regulated computerized systems throughout their lifecycle. The role provides technical leadership in validation strategy, execution, quality review, audit and inspection readiness, while serving as a subject matter expert in CSV/CSA, SDLC, data integrity, electronic records/signatures, and regulatory requirements. The position also provides mentorship to junior CSV/CSA team members. RESPONSIBILTIES Validation and Assurance Strategy : Lead planning, execution, review, and approval of validation and assurance deliverables for new GxP systems, system upgrades, integrations, infrastructure changes, software changes, and system retirements, Determine appropriate validation or assurance rigor using risk-based principles aligned with GAMP 5, CSA, data integrity, e-record/e-signature, and applicable GxP expectations, Lead or review system risk assessments, validation strategy assessments, supplier/vendor assessments, impact assessments, and validation planning decisions, Ensure validation strategies are proportionate to system risk, intended use, business process impact, patient/subject safety, product quality, data integrity, and regulatory impact. CSV/CSA Deliverables : Author, review, or approve validation lifecycle deliv