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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 https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Automation Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

US065 NJ Raritan - 700 Route 202 S, US121 NJ Raritan - 1000 Highway 202 S

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 Engineer, Automation - CAR-T to be 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.

Are you interested in joining a team that is passionate about improving the lives of cancer patients?

This new position is part of the MAKE Operational Technology Team and will work closely with the Site Lead of Supply Chain Systems. The Staff Automation Engineer for Cell Therapy manufacturing will engage in collaboration with multi-functional teams to implement solutions across automation platforms deployed in Raritan. A robust background in ISA-95 Level 0 to Level 2 automation is essential for this role.

Key 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.

Qualifications:

Education:

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

Experience and Skills:

Required:

• A minimum 5 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.

• Proven 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.

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.

Other:

• This position is required to be on site 3 days per week and requires up to 5% domestic and international travel, based on business needs.

Why Join Us? This role presents a unique opportunity to lead transformative initiatives in Cell Therapy Supply Chain Systems and Automation, promoting standard processes in technology solutions management and supporting business objectives. If you're a visionary leader passionate about operational excellence and continuous improvement, we invite you to be part of our transformative journey. This position is a great opportunity for high-potential talent looking for accelerated development and providing hope to cancer patients.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ra-employeehealthsup@its.jnj.com ) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$91,000 to $147,000.

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits