Senior QA Specialist - CSV

Johnson & Johnson Innovative Medicine•Wilson, NC

1d•Onsite

About The Position

Johnson & Johnson is seeking a Senior QA Specialist - CSV to join the Quality team at its new Biotherapeutics Manufacturing facility in Wilson, North Carolina. The role provides quality assurance oversight for computerized systems validation (CSV), data integrity, and qualification of systems and technologies being established at the greenfield site. This includes automated manufacturing and laboratory systems, digital and AI-enabled technologies, and connected manufacturing systems. The specialist will develop and maintain site CSV and data integrity procedures, advise project teams, and apply risk-based validation approaches across the system lifecycle. The role includes reviewing and approving lifecycle documentation, ensuring requirements are traced and systems are qualified and released for GMP use, and overseeing data integrity, cybersecurity, supplier quality, and regulatory inspection readiness. The specialist will also support the transition of systems into operations, lead or support investigations and CAPAs, and build CSV capability through training and mentoring.

Requirements

Bachelor's degree in a scientific, engineering, or computer science discipline.
At least 6 years of relevant experience in the biological and/or pharmaceutical industry, with substantial hands-on experience in computerized system validation or computerized system quality assurance.
Hands-on QA oversight of CSV for automated manufacturing equipment and systems such as PLC/DCS/SCADA/MES, and GMP laboratory systems such as LIMS and CDS.
Strong working knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5 (2nd Edition), and data integrity expectations from FDA, MHRA, PIC/S, and WHO.
Demonstrated application of risk-based, critical-thinking validation approaches, including GAMP 5 (2nd Edition), ICH Q9(R1), FDA Computer Software Assurance principles, supplier documentation, and avoidance of duplicate testing.
Experience with SDLC and qualification of facilities, utilities, and equipment, including integrated commissioning and qualification under ASTM E2500.
Experience leading or supporting deviations, investigations, and CAPAs.
Strong technical writing skills.
Integrity and commitment to ethical conduct and regulatory requirements; promotes a culture of quality.
Sound judgment and ability to make pragmatic risk-based decisions, solve complex problems, and escalate when appropriate.
Ability to communicate complex quality concepts across organizational levels, manage conflict constructively, and drive alignment across Engineering, Automation, IT, Operations, QC, and suppliers.
Strong project management skills and ability to manage multiple priorities and deadlines in a fast-paced project environment with minimal supervision.
Detail-oriented and analytical approach focused on process improvement.

Nice To Haves

Validation experience with sterile fill-finish, isolator or RABS automation, and EMS/PAS systems supporting EU GMP Annex 1 and a Contamination Control Strategy.
Experience with automated visual inspection (USP <790>/<1790>) and validation of AI/ML-enabled systems.
Experience with combination products or device assembly (21 CFR Part 4, 21 CFR Part 820/QMSR, FDA Computer Software Assurance guidance), or serialization (DSCSA, EU FMD).
MES/electronic batch record experience, including ISA-88 recipe management, review by exception, and ISA-95 enterprise integration.
Knowledge of OT cybersecurity (ISA/IEC 62443), alarm management (ISA-18.2), and cloud/SaaS supplier oversight.
Familiarity with ICH Q10, EU GMP Annex 15, the evolving EU GMP Annex 11 revision, and Annex 22 (Artificial Intelligence).
Greenfield, start-up, or large capital project experience.
Experience supporting FDA, EMA, or other regulator inspections, including pre-approval or pre-license inspections.
Experience with digital validation tools such as Kneat or ValGenesis and platforms such as DeltaV, Rockwell, Siemens, PAS-X or Syncade, LabWare, Empower, OSIsoft PI, and SAP.

Responsibilities

Author, implement, and maintain site CSV and data integrity procedures; contribute to the Validation Master Plan, computerized system inventory, and GxP/criticality assessments.
Represent Quality Assurance on qualification teams throughout requirements, design review, construction, commissioning, qualification, and implementation; advise project management on quality systems for new technologies.
Apply risk-based validation principles, integrating commissioning and qualification, leveraging supplier and FAT/SAT documentation, and right-sizing testing based on patient safety, product quality, and data integrity risk.
Review and approve lifecycle deliverables, including requirements and design specifications, testing and qualification documentation, risk assessments, traceability matrices, data integrity assessments, supplier assessments, deviations, and validation reports.
Ensure requirements are traced, tested, and qualified throughout the project lifecycle and that facilities, utilities, and systems are released for GMP manufacturing use.
Ensure deviations and test exceptions are documented, evaluated, approved, and closed; lead or support investigations and CAPAs.
Establish and oversee audit trail review, access management, backup and restore, archiving, and data lifecycle controls, including OT/IT network segmentation.
Provide QA oversight of AI/ML-enabled inspection systems, including data governance, performance metrics, locked models, and model change control; oversee automated visual inspection alignment with applicable USP standards.
Ensure validation of EMS/PAS alarms and audit trails, isolator decontamination automation, and system data supporting the site Contamination Control Strategy.
Oversee qualification of MES and electronic batch records, including recipe management, review by exception, and integration across MES, ERP, LIMS, and automation; ensure alarm management practices align with ISA-18.2.
Assess and audit system integrators, platform suppliers, and cloud/SaaS providers, including quality agreements and service-level expectations.
Evaluate quality, compliance, data integrity, and cybersecurity impacts of process or system changes; support system upgrades and modifications.
Lead project-to-operations handover, including system ownership, periodic review, operational change control, and incident/problem management; maintain validated state through periodic review and revalidation as needed.
Prepare systems and data for regulatory inspections, including system narratives and system demonstrations.
Report and escalate quality risks and issues to Quality Leadership; implement lessons learned and best practices.
Train personnel in Computerized Systems Operations and Maintenance and mentor team members to build CSV capability across the site.