Automation Engineer I - Princeton NJ

Senior Engineer I

The Senior Engineer I serves as the system owner and lifecycle steward for integrated automation systems supporting analytical methods in late-stage and commercial cell therapy programs. This role is responsible for maintaining systems in a validated and inspection-ready state across GMP and non-GMP laboratories. The position drives governance of technology transfers from Analytical Development/QC into ASAT, oversees system validation activities, and provides operational ownership, end-user support, and training. The role works cross-functionally with Analytical Development, Quality Control, Quality Assurance, IT, and manufacturing stakeholders to ensure automation systems meet business needs while maintaining compliance with cGMP and data integrity requirements.

System Ownership & Lifecycle Management

Serve as the designated system owner for automated analytical platforms within ASAT, maintaining systems in a validated and inspection-ready state. Govern the full validation lifecycle (IQ, OQ, PQ), including protocol approval, execution oversight, periodic reviews, and revalidation activities. Maintain validation documentation including validation master plans, traceability matrices, SOPs, change controls, and deviation reports. Ensure compliance with 21 CFR Part 11, Annex 11, data integrity principles, and applicable cGMP regulations. Coordinate planned and unplanned system maintenance, upgrades, patches, and configuration changes through formal change control processes.

Method & Technology Transfer

Lead the technical transfer of automated analytical methods from Analytical Development into ASAT for commercial support. Collaborate with development teams to define transfer requirements and assess platform readiness for commercial operation. Oversee development and execution of technology transfer protocols, gap assessments, and comparability studies. Ensure transferred methods and systems meet commercial manufacturing and regulatory filing requirements.

End-User Support & Training

Provide day-to-day technical support to laboratory users operating automated systems. Develop and deliver training programs on system operation, troubleshooting, and compliance requirements. Create and maintain user guides, quick-reference materials, and training documentation. Serve as the primary escalation point for system issues, coordinating with vendors and IT.

Cross-Functional Collaboration & Continuous Improvement

Partner with QA, QC, IT, and manufacturing teams to support regulatory inspections, audits, and CAPA activities. Identify opportunities to optimize system performance, improve throughput, and reduce assay variability. Evaluate and recommend system upgrades and new automation technologies in collaboration with development teams and vendors. Foster user community of best practice and drive multisite harmonization. Should be able to work across cross functional team and across sites.