Staff Automation Engineer

Johnson & Johnson Innovative Medicine • Raritan, NJ

23h • $94,000 - $144,500 • Onsite

About The Position

We are searching for the best talent for 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 is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.
The Staff Automation Engineer will engage in collaboration with multi-functional teams to implement solutions across automation platforms deployed in Raritan.
Automation is a dedicated team of enthusiastic and skilled Automation professionals with various technical expertise, responsible for the (support of) implementation, validation, qualification and maintenance of the ISA-95 level 0 to level 2 manufacturing automated systems and applicable interfaces and level 3 recipe content for the manufacturing facility.
Automation team leads a service contractor group for 24/7 support and base business administration. This role will supervise the handled service team and also run automation project such as system upgrades or process improvements.

Requirements

• A minimum of a Bachelor’s degree is required.
• A minimum 7-8 years of relevant professional experience within a regulated pharmaceutical or biotechnology manufacturing environment is required.
• 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. Experience with real-time data integration to steer optimizations for manufacturing process is preferred.
• Excellent interpersonal skills (written, verbal, and presentation). Must have the ability to influence and make data-driven decisions according to the J&J Credo.
• A technical education / degree in industrial automation, information technology or relevant Engineering field is required.
• 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

Nice To Haves

• A Master’s degree in Systems Engineering, Mechatronic, Computer Science, or a related field; advanced degrees (e.g., MBA) is preferred.
• 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.

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-out on system performance and business metrics.
• Ensure all aspects user requirement specifications and all applicable objectives are met to maintain the automation platforms (e.g. backup, disaster recovery, user administration etc.).
• 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 the 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 necessary.
• Support the Raritan site readiness for FDA and health authority audits, as necessary.
• Establish effective relationships with Operations, Manufacturing Science and Technology, Quality, IT, Facilities, and Global teams within both Johnson & Johnson and Legend Biotech.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior