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 at the Raritan site. Configure interfaces, ensure system compliance, and serve as the single point of contact for ISA-95/88 L0-L2 automation systems. Drive operational technology change while overseeing external managed service providers and supporting OT cybersecurity workstreams. Author validation test protocols per GxP, coordinate system reviews, and manage change controls to maintain quality commitments. Define, monitor, and report-out on system performance metrics to support continuous improvement and new technology introductions.
Required Qualifications
- A minimum of a Bachelor's degree
- A Master's degree in Systems Engineering, Mechatronic, Computer Science, or a related field
- 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)
- Experience engaging in FDA and/or Health Authority regulatory audits and inspections
Desired Qualifications
- A Master's degree in Systems Engineering, Mechatronic, Computer Science, or a related field; advanced degrees (e.g., MBA) is preferred
- 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
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