Senior Computer System Validation Specialist

Job Title: Senior Computer System Validation Specialist Department: IT Quality & Validation Location: Remote Hours Per Week: 40 Schedule: Monday - Friday SUMMARY The Senior Computer System Validation (CSV) Specialist is responsible for leading the planning, execution, and documentation of validation activities for GxP-regulated computerized systems. This role ensures compliance with regulatory expectations, internal policies, and industry standards. The Senior CSV Specialist provides technical leadership, supports audits, mentors junior staff, and collaborates with cross-functional teams to maintain validated systems across their lifecycle. The Senior CSV Specialist maintains a key responsibility with ACM’s Quality department, understands and honors the commitment IT makes to operate under the Quality framework. The Senior CSV Specialist is the primary author for all typical CSV deliverables for ISPE GAMP systems under a legacy CSV model as well as a Computer Software Assurance (CSA) model; including validation plans, functional requirements, user requirements, installation qualification test protocols, operational qualification test protocols, user acceptance test scripts, validation trace matrices, validation summary reports. RESPONSIBILITIES Lead development and execution of validation deliverables for new systems, upgrades, and changes, including: User Requirements Specifications (URS), Functional/Design Specifications (FS/DS), Validation Plans (VP) o Risk Assessments (including data integrity and cybersecurity), IQ/OQ/PQ protocols and reports, Traceability Matrices Execute testing, manage defects, and ensure complete, accurate documentation of validation evidence. · Ensure appropriate validation rigor using a risk-based approach aligned with GAMP 5 and CSA principles (where applicable). Ensure systems comply with: US FDA Computer Software Assurance Guideline, GxP (GMP/GLP/GCP), 21 CFR Part 11, EU Annex 11, ISPE GAMP 5, Data Integrity (ALCOA+) Support internal/e...