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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.
Qualifications
Education:
- A minimum of a Bachelor’s Degree and or equivalent degree required; preferred area(s) of study in Supply Chain, Information Technology, Data Science, or Computer Science, Engineering,
Experience and Skills:
Required:
- A Minimum 4 years experience in MES (PAS-X) eBR Development and Master Data Management in a Pharmaceutical Manufacturing System/Process (GxP) environment.
- Working Knowledege of ISA-88 (Standards for Process Control) and ISA-95 (Standards of Automated Interfaces) and experience with MES System Integrations (ERP, eLIMs, etc.).
- Practical experience in Software Development Lifecycle (SDLC), Computer System Validation (CSV), and Data Integrity (DI) standards, including FDA 21 CFR Part 11.
- Ability to Work Cross-Functionally, Influence Decision Making, and Present to Leadership.
- Excellent Written, Oral, and Listening Communication Skills.
- Proficiency with MS Office Suite (Excel, PowerPoint, SharePoint, etc.).
Preferred:
- Expertise in Process Level (0-2) Automation (OSI-PI Historian, SCADA/DCS).
- Familiar with Chain of Identity (CoI) and Chain of Custody (CoC) systems.
- Experience participating in FDA and/or Other Regulatory Audits / Inspections.
- Experience developing KPIs and Analytical Dashboards (Tableau, PowerBI, or Navigate).
- Certification(s) in Project Management (FPX, CAPM, or PMP) and/or Process Improvement (Lean Six Sigma).
- High Affinity for Next-Gen MES Technologies, Automation, and Complex Processes.
Other:
- Requires up to 5% Travel (Domestic and International).
- 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 anticipated base pay range for this position is $76,000 to $121,900.
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)).
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
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal, and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits .
This job posting is anticipated to close on April 21, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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.
