Staff Automation Engineer

Role: Staff Automation Engineer supporting biopharmaceutical manufacturing at Johnson & Johnson's Raritan site. Responsibilities include leading development, qualification, and lifecycle management of process automation systems across ISA-95 levels 0-2, ensuring system compliance and performance monitoring. The role involves configuring interfaces, authoring validation protocols within GxP frameworks, managing change controls, and driving automation improvements and technology adoption, including OT cybersecurity support. The engineer supervises service teams and manages automation projects like system upgrades and process enhancements. Qualifications: Bachelor’s degree in Systems Engineering, Mechatronics, Computer Science, or related field; 7-8+ years of experience in regulated pharma/biotech manufacturing; deep expertise in operational technology (e.g., ISA-95/88, Rockwell PLC, DeltaV DCS, OSI-PI), system validation, and compliance with FDA 21 CFR Part 11 and EU Annex 11. Preferred skills include experience with Pharma 4.0, digital transformation, Cell Therapy COC/COI systems, and familiarity with Data Lakes, visualization tools, and regulatory audits. HighValue: focus on automation within biologics or cell therapy manufacturing, supporting FDA and health authority inspections, implementing Industry 4.0 initiatives. Work setup: based in Raritan, NJ, with supervision of external service teams and collaboration with cross-functional departments. Technical, project management, and cybersecurity expertise are emphasized.