Co-Op, MES Engineer

2406206624W

Johnson & Johnson is currently seeking a Co-Op, MES Engineer, 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 Supply Chain Systems team. A fantastic role for high potential talent seeking accelerated development!

Key Responsibilities:

• Perform MBR Development, Modeling, and Version-Ups in MES (PAS-X) to support the process evolution and expansion of our CAR-T Manufacturing at the Raritan Site.
• Support the integration of Supply Chain Systems (ERP, eLIMs, OSI-PI Historian, Data Lake, etc.) with MES.
• Support execution of MES Validation 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).
• Ensure compliance of delivered work with local Raritan procedures (e.g. SOPs, WIs, Technical & Design Specifications, and Qualification Protocols).

Qualifications:

Education:

• Currently pursuing a Bachelor’s/Masters Degree in one of the following area(s) of study in Supply Chain, Information Technology, Data Science, or Computer Science, Engineering. Equivalent degrees will be considered.

Experience and Skills:

Required:

• High interest in supply chain system and MES (PAS-X) MBR modeling (recipe development) and Master Data Management in a Pharma Manufacturing System and (GxP) environment.
• Knowledege or interest in ISA-88 (Standards for Process Control) and ISA-95 (Standards of Automated Interfaces) and experience with MES System Integrations (ERP, eLIMs, etc.).
• Knowledege or interest in Software Development Lifecycle (SDLC), Computer System Validation (CSV), and Data Integrity (DI) standards, including FDA 21 CFR Part 11.
• Excellent Written, Oral, and Listening Communication Skills.
• Proficiency with MS Office Suite (Excel, PowerPoint, SharePoint, etc.).

Preferred:

• High Affinity for Next-Gen MES Technologies, Automation, and Complex Processes.
• Knowledge of Process Level Automation and ISA-88/95 Standards
• Pursuing or received certification(s) in Project Management (FPX, CAPM, or PMP) and/or Process Improvement (Lean Six Sigma).

Other:

• Adhere to J&J Flexible Work Policy - On-site a minimum of 3 days each week, with the option for 2 remote workdays each week.

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.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.