Staff Automation Engineer

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for a Staff Automation Engineer to be based in Raritan, NJ. Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership combines the strengths and expertise of both companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

Responsibilities

• Lead and execute technical development, qualification, planning, and lifecycle activities for process automation systems.
• Configure interfaces and ensure system compliance to local and global standards.
• Drive operational technology change, serving as the business SME and product owner for process automation, PIMS OSI-PI, Rockwell PLC, DeltaV DCS, and Siemens Desigo EMS.
• Be the single point of contact for ISA-95/88 L0-L2 automation systems deployed at the Raritan site.
• Define, monitor, and report on system performance and business metrics.
• Ensure all aspects of user requirement specifications and applicable objectives are met to maintain the automation platforms (e.g., backup, disaster recovery, user administration).
• Author and execute validation test protocols within the electronic document validation system (Kneat) per GxP.
• Coordinate periodic system reviews for the deployed automation.
• Hold and support change controls, non-conformances, and corrective and preventive actions to ensure quality commitments are met relative to automation.
• Use industry experience to identify continuous improvement opportunities. Lead and steer automation improvement projects and assessments for new technology introduction.
• Be responsible for the oversight and effective delegation of automation development activities to external managed service providers and internal partners, as necessary.
• Support the OT cybersecurity workstream for the site, as needed.
• Support the Raritan site readiness for FDA and health authority audits, as needed.
• Establish effective relationships with Operations, Manufacturing Science and Technology, Quality, IT, Facilities, and Global teams within both Johnson & Johnson and Legend Biotech.

Requirements

A minimum of a Bachelor’s degree is required. A Master’s degree in Systems Engineering, Mechatronics, Computer Science, or a related field—or advanced degrees (e.g., MBA)—is preferred.

Qualifications

• A minimum of 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.
• Strong emphasis on driving accelerated technology adoption and moving the needle. Experience with real-time data integration to steer optimizations for manufacturing processes is preferred.
• Excellent interpersonal skills (written, verbal, and presentation). Ability to influence and make data-driven decisions according to the J&J Credo.

Preferred Qualifications

• 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.

Skills

• Required: Technical education/degree in industrial automation, information technology, or relevant Engineering field.
• Preferred: 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.

Pay

The anticipated base pay range for this position is $94,000–$144,500.

Benefits

• Vacation: 120 hours per calendar year
• Sick time: 40 hours per calendar year (56 hours for employees who reside in the State of Washington)
• Holiday pay, including Floating Holidays: 13 days per calendar year
• Work, Personal and Family Time: up to 40 hours per calendar year
• Parental Leave: 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave: 30 days for an immediate family member; 5 days for an extended family member
• Caregiver Leave: 10 days
• Volunteer Leave: 4 days
• Military Spouse Time-Off: 80 hours