Staff Automation Engineer
$94,000–$144,500 year
On-siteRaritan, New Jersey, United States
Job Summary
Lead and execute technical development, qualification, planning, and lifecycle activities for process automation systems supporting ISA-95 level 0 to 2 manufacturing automated systems and applicable interfaces at the Raritan site. Configure interfaces, define user requirement specifications, and ensure system compliance to local and global standards while serving as the single point of contact for deployed automation. Drive operational technology change and oversee external managed service providers, managing system upgrades, process improvements, and change controls to maintain quality commitments relative to automation. Monitor and report system performance metrics, coordinate periodic system reviews, and support OT cybersecurity workstreams and FDA/health authority audit readiness. Establish effective relationships with Operations, Manufacturing Science, Quality, IT, and Global teams to champion continuous improvement and new technology introduction within the CAR T-cell therapy development environment.
Required Qualifications
- A minimum of a Bachelor's degree
- A minimum 7-8 years of relevant professional experience within a regulated pharmaceutical or biotechnology manufacturing environment
- In-depth technical knowledge of operational technology; ISA-95/88 L0-L2 systems, including instrumentation, Rockwell PLC/SCADA, OSI-PI PIMS, DeltaV DCS, and Desigo EMS
- Experience integrating L2 and L3 enterprise systems (e.g. SCADA to PAS-X MES)
- Extensive experience in merging OT and IT systems, and defining fit for purpose hardware and software design specifications according to ISPE GAMP-5
- Validated practical knowledge of maintaining cGxP regulations related to CSV including FDA 21 CFR Part 11 and EU Annex 11
- Must have a strong emphasis on driving accelerated technology adoption and moving the needle
- A technical education / degree in industrial automation, information technology or relevant Engineering field
- Must have the ability to influence and make data-driven decisions according to the J&J Credo
- Excellent interpersonal skills (written, verbal, and presentation)
Desired Qualifications
- A Master's degree in Systems Engineering, Mechatronic, Computer Science, or a related field
- advanced degrees (e.g., MBA)
- Experience with real-time data integration to steer optimizations for manufacturing process
- Appreciation of Pharma 4.0, digital transformation, IOT, cybersecurity and data
- Experience with Cell Therapy Chain of Custody (COC) and Chain of Identity (COI) systems
- Certification in Process and/or Project Management, e.g., Lean Six Sigma, PMP, Agile PM
- Knowledge of Data Lake and Data Visualization Tools; e.g, PowerBI, Tableau, PI Vision
- Experience engaging in FDA and/or Health Authority regulatory audits and inspections
- Artificial Intelligence (AI)
- Controls Compliance
- Critical Thinking
- Industrial Robotics
- Industry Analysis
- Innovation
- Lean Supply Chain Management
- Machine Learning (ML)
- Management Systems Implementation
- Organizing
- Problem Solving
- Project Management
- Prototyping
- Robotic Automation
- Science
- Technology, Engineering, and Math (STEM) Application
- Smart Systems
- Technologically Savvy
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