Staff Automation Engineer

Johnson & Johnson • Raritan, NJ

1d • Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Automation Engineering Job Category: Scientific/Technology All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: 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. Learn more at https://www.jnj.com/innovative-medicine 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.
• 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.
• Required Skills: 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.
• Experience with real-time data integration to steer optimizations for manufacturing process 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.
• Preferred Skills: 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

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; for employees who reside in the State of Washington –56 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