Senior QA Specialist - CSV

Johnson & Johnson•Wilson, NC

3d•Onsite

About The Position

Johnson & Johnson is seeking a Senior QA Specialist - CSV to join its Quality team at the new Biotherapeutics Manufacturing facility in Wilson, North Carolina. The role provides quality assurance oversight for computerized system validation (CSV), data integrity, and qualification activities at a greenfield manufacturing site. It spans system lifecycles from requirements and design through construction, commissioning, qualification, implementation, release, and ongoing operations. The specialist will establish site CSV and data integrity procedures and provide risk-based oversight of manufacturing, laboratory, digital, AI-enabled, and connected systems. The role ensures systems and data meet applicable GMP requirements, are ready for regulatory inspections, and remain in a validated state through operational handover, periodic review, and revalidation as needed. The specialist also supports continuous improvement, escalates quality risks, and trains and mentors personnel in computerized systems operations and maintenance.

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, including substantial hands-on computerized system validation or computerized system quality assurance experience.
Hands-on QA oversight of CSV for automated manufacturing equipment and systems such as PLC, DCS, SCADA, or MES, and GMP laboratory systems such as LIMS or 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 use of risk-based, critical-thinking validation approaches, including GAMP 5 (2nd Edition), ICH Q9(R1), and FDA Computer Software Assurance principles; experience leveraging supplier documentation and avoiding duplicate testing.
Experience with Software Development Life Cycle (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.
High integrity and commitment to ethical conduct and regulatory compliance.
Ability to make pragmatic, risk-based decisions, solve complex problems, and escalate issues appropriately.
Ability to communicate complex quality concepts across organizational levels, manage conflict constructively, and align Engineering, Automation, IT, Operations, QC, and suppliers.
Strong project management skills, ability to manage multiple priorities and deadlines in a fast-paced project environment with minimal supervision, and a detail-oriented, analytical approach to continuous 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 under USP <790>/<1790> and validation of AI/ML-enabled systems.
Experience with combination products or device assembly, including 21 CFR Part 4, 21 CFR Part 820/QMSR, or FDA Computer Software Assurance guidance, or experience with serialization such as DSCSA or 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, and contribute to the Validation Master Plan, computerized system inventory, and GxP and criticality assessments.
Represent Quality Assurance on qualification teams through requirements, design review, construction, commissioning, qualification, and implementation; ensure applicable quality, regulatory, engineering, safety, and process requirements are met.
Advise project management on appropriate quality systems for new computerized systems.
Apply risk-based validation principles, integrating commissioning and qualification, using supplier documentation and FAT/SAT evidence, and scaling testing according to risk to patient safety, product quality, and data integrity.
Review and approve lifecycle deliverables as needed, including requirements and design specifications, testing and qualification protocols and reports, risk and data integrity assessments, traceability matrices, supplier assessments, diagrams, code reviews, deviations, validation master plans, and validation summary 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 restoration, archiving, and data lifecycle controls, including OT/IT network segmentation.
Provide QA oversight of AI/ML-enabled inspection systems, including training and test data governance, performance metrics, locked models, and model change control; oversee automated visual inspection aligned with USP <790>/<1790>.
Ensure validation of EMS/PAS alarms and audit trail functionality, isolator decontamination cycle automation, and system data supporting the site Contamination Control Strategy.
Oversee qualification of MES and electronic batch records, including ISA-88 recipe management, review by exception, and ISA-95 integration across MES, ERP, LIMS, and automation; ensure alarm management aligns with ISA-18.2.
Assess and audit system integrators and platform suppliers, including cloud/SaaS providers, and address quality agreements and service-level expectations.
Evaluate the quality impact of process and system changes and support GxP system upgrades and modifications from quality, compliance, data integrity, and cybersecurity perspectives.
Lead project-to-operations handover, including system ownership, periodic review, operational change control, and incident/problem management; maintain validated state through review and revalidation as necessary.
Prepare systems and data for FDA, EMA, and other regulator inspections, including pre-approval and pre-license inspections; prepare system narratives and lead demonstrations.
Escalate quality risks and issues to the Quality Leadership team and implement lessons learned and best practices.
Train personnel in Computerized Systems Operations and Maintenance and mentor team members to build site CSV capability.