Senior QA Specialist - CSV

Johnson & Johnson

Estimated pay: Est. $19–$29/hr (market estimate, not employer-stated)

Shift: Full time

At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Documentation Job Category: Professional All Job Posting Locations: Wilson, North Carolina, United States of America Job Description: We are currently seeking a highly qualified individual to join our team as a Senior QA Specialist - CSV at our new Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC). Key Responsibilities: Program build: Author, implement, and maintain site CSV and data integrity procedures; contribute to the Validation Master Plan, computerized system inventory, and GxP/criticality assessments. Project QA oversight: Represent Quality Assurance on qualification teams across requirements, design review, construction, commissioning, qualification, and implementation to ensure quality, regulatory, engineering, safety, and process requirements are met for technologies being established at our greenfield site (including AI-enabled inspection, ASRS, AMRs, digital validation, and connected manufacturing systems). Provide consulting to the project management team to ensure appropriate quality systems are in place for new systems. Risk-based validation: Apply GAMP 5 (2nd Edition) critical thinking, ICH Q9(R1), and ASTM E2500 principles to integrate commissioning and qualification, leverage supplier documentation and FAT/SAT evidence, and right-size testing based on risk to patient safety, product quality, and data integrity. Lifecycle deliverables: Review and approve URS, FRS, HDS, SDS, configuration specifications, Unit Integration Testing, FAT, SAT, IQ, OQ, PQ, risk assessments, Requirements Traceability Matrix, data integrity assessments, data/process flow diagrams, supplier assessments, interface and integration testing, code reviews, deviations, validation master plans, and validation summary reports, as needed. Traceability and release: Ensure all requirements are properly traced, tested, and qualified across the project lifecycle, and that facilities, utilities, and systems are properly released for use in GMP manufacturing. Deviations and exceptions: Ensure all deviations and test exceptions are properly documented, evaluated, approved, and closed across project testing phases; lead or support investigations and CAPAs. Data integrity and cybersecurity: Establish and oversee audit trail review, access management, backup/restore, archiving, and data lifecycle controls in accordance with 21 CFR Part 11, EU GMP Annex 11, and ISA/IEC 62443 (including OT/IT network segmentation). Advanced and AI-enabled technologies: Provide QA oversight of AI/ML-enabled inspection systems, including training and test data governance, performance metrics, static (locked) models, and model change control, as well as automated visual inspection aligned with USP 790 / 1790 . Annex 1 alignment: Ensure validation of EMS/PAS alarm and audit trail functionality, isolator decontamination cycle automation, and system data that supports the site Contamination Control Strategy. MES and execution systems: Oversee qualification of MES/electronic batch records, including ISA-88 recipe management, review by exception, and ISA-95 integration across MES, ERP, LIMS, and automation layers; ensure alarm management practices align with ISA-18.2. Supplier oversight: Assess and audit system integrators and platform suppliers (DCS/PLC, MES, LIMS, AVI, serialization) and cloud/SaaS providers, including quality agreements and service level expectations. Change control: Evaluate the potential impact of process or system changes on product quality, and support upgrades, modifications, or changes to GxP system components from a quality, compliance, data integrity, and cybersecurity perspective. Operational readiness: Lead the project-to-operations handover, including system ownership, periodic review, operational change control, and incident/problem management; ensure systems maintain their validated state through periodic review and revalidation as necessary. Inspection readiness: Ensure systems and data are ready for pre-approval and pre-license inspections by FDA, EMA, and other regulators, including preparing system narratives and leading system demonstrations. Escalati