Senior Execution Systems Engineer, Car-T

Johnson & Johnson is currently seeking a Senior Systems Engineer (MES), CAR-T to join our TEAM!

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/.

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 making a difference in a growing company thriving on a diverse culture, celebrating the uniqueness of our employees, and committed to inclusion? Apply today for this phenomenal opportunity!

This exciting new role sits on our E2E Advanced Therapies Cell Therapy MAKE Manufacturing Team and works with the Site Lead of Supply Chain Systems. A fantastic role for high potential talent seeking accelerated development!

Key Responsibilities:

• Lead eBR Development, Version-Ups, and Perform Modeling in MES (PAS-X) to support the process evolution and expansion of our CAR-T Manufacturing at the Raritan Site.

• Serve as the MES Subject Matter Expert for Raritan Advanced Therapies to support various Capital Projects and Site Initiatives requiring MES Enhancements and Manufacturing Data.

• Integrate Supply Chain Systems (ERP, eLIMs, OSI-PI Historian, Data Lake, etc.) with MES.

• Coordinate and Execute MES Validation Activities according to the Software Development Lifecycle (e.g. Commissioning Test Plans (CTP), Installation/Operational Qualification (IOQ).

• Collaborate with US Operations, Automation, Manufacturing Excellence, MSAT, Quality, PMO, IT Infrastructure, Digital/D&A, and partners at Legend Biotech to ensure robust and detailed Base Business support of the site's Manufacturing Execution System (MES).

• Define Standardizations and Update Documentation (e.g. SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures.

• Participate in System Capability Sprints/Release Planning, and Demos with partners.

• Act as the Site MES SME to support Quality Investigations, Corrections, and QMS records.

• Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.