Automation Engineer I - Princeton NJ

Company: Msccn
Location: Princeton
Posted on: April 2, 2026

Job Description:

Job Description ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Role Summary 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. Key Responsibilities 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. Additional Qualifications/Responsibilities Qualifications BS or MS in engineering, computer science, or a related scientific discipline with 4 years of experience in automation systems within a regulated environment. Demonstrated experience governing system validation activities (IQ, OQ, PQ) and lifecycle management in GMP environments. Experience supporting technology transfer of automated analytical methods from development to commercial operations. Working knowledge of integrated automation platforms such as Biosero, HighRes Biosolutions, Thermo Scientific, or equivalent systems. Experience in Automating Filling, capper decapper is plus. Strong understanding of 21 CFR Part 11, Annex 11, data integrity principles, and cGMP requirements. Experience authoring and maintaining validation documentation, SOPs, change controls, and deviation reports. Experience programming or troubleshooting liquid handling and automation workflows. Excellent problem-solving, verbal, written, and interpersonal communication skills. Preferred Qualifications Experience deploying and maintaining automation systems in GxP environments. Experience managing and coordinating multiple automation vendors. Experience supporting regulatory inspections or audits related to automated systems. Familiarity with LIMS integration and laboratory informatics systems If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Madison - Giralda - NJ - US: $100,100 - $121,293 Princeton - NJ - US: $100,100 - $121,293

Keywords: Msccn, Philadelphia , Automation Engineer I - Princeton NJ, IT / Software / Systems , Princeton, Pennsylvania