Senior QA Specialist CSV

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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.
• Escalation and continuous improvement: Report and escalate quality risks/issues to the Quality Leadership team; implement lessons learned and best practices from other internal and external projects.
• Training and capability building: Train personnel in Computerized Systems Operations and Maintenance and mentor team members to build CSV capability across the site organization.

Required:

• A Bachelors degree in a scientific engineering or computer science discipline.
• A minimum of 6 years relevant experience working within the biological and/or pharmaceutical industry with substantial hands-on experience in computerized system validation or computerized system quality assurance.
• Hands-on experience with QA oversight of CSV for automated manufacturing equipment and systems (PLC/DCS/SCADA/MES) and GMP laboratory systems (e.g. LIMS CDS).
• Strong working knowledge of 21 CFR Part 11 EU GMP Annex 11 GAMP 5 (2nd Edition) and data integrity expectations (FDA MHRA PIC/S WHO).
• Demonstrated application of risk-based critical-thinking approaches to validation (GAMP 5 2nd Edition ICH Q9(R1) FDA Computer Software Assurance principles) including leveraging supplier documentation and avoiding duplicate testing.
• Experience with Software Development Life Cycle (SDLC) and the qualification of facilities utilities and equipment including integrated commissioning and qualification (ASTM E2500).
• Experience leading or supporting deviations investigations and CAPAs.

Preferred:

• 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 with 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 and 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 (e.g. Kneat ValGenesis) and platforms such as DeltaV Rockwell Siemens PAS-X or Syncade LabWare Empower OSIsoft PI and SAP.
• Strong technical writing skills.

Key Competencies:

• Integrity and quality mindset: High integrity and commitment to operating ethically within regulatory requirements; promotes a culture of quality.
• Sound judgment: Makes pragmatic risk-based decisions independently solves complex problems and knows when to escalate.
• Influence and communication: Conveys complex quality concepts to all levels manages conflict constructively and drives alignment across Engineering Automation IT Operations QC and suppliers.
• Execution: Strong project management skills; manages multiple priorities and deadlines in a fast-paced project environment with minimal supervision.
• Continuous improvement: Detail-oriented and analytical with a focus on process improvement.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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