SENIOR ENGINEER, EXECUTION SYSTEMS - CAR-T

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Engineer, Execution Systems - CAR-T! At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.
Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science.
We are Janssen.
We collaborate with the world for the health of everyone in it.
Learn more at www.
anssen.
om and follow us @JanssenGlobal.
Janssen Biotech, Inc.
is part of the Janssen Pharmaceutical Companies.
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? We work on the most sophisticated treatment options available today.
To support the global CAR-T program, Janssen is rapidly growing its manufacturing and laboratory capabilities.
This position offers a perfect environment to transform CAR-T Cell Therapy manufacturing and the underlying supply chain systems, into something unique given the limited amount of Cell Therapy manufacturers worldwide.
Apply today for this exciting chance to be part of the #CAR-T team! Our Raritan, NJ Cell Therapy facility is scaling up operational flows to serve more patients and meet the highest quality standards without compromising manufacturing efficiency.
This exciting new role reports to the Site Lead of CAR-T Supply Chain Systems and will be tasked with the enhancing Raritan's current MES capabilities.
The individual will design, plan, and implement Electronic Batch Records with the goal to transform the site into a paper-less manufacturing facility.
The Senior Engineer should be passionate about data and will collaborate with Janssen's CAR-T supply chain team to acquire business insights and propose data-driven solutions.
All Master Batch Record modelling will be done in the PAS-X MES software.
This is an outstanding opportunity to sit on an E2E Supply Chain team and develop next generation MES knowledge and business experience.
A fantastic role for high potential talent seeking accelerated career development and growth.
Key Responsibilities.
Collaborate with Operations, Manufacturing Excellence, MS&T, Quality, IT, and partners at Legend Biotech to ensure the flawless base business support of the PAS-X Manufacturing Execution Systems (MES).
Lead development and perform modeling of eBRs in MES to accommodate CAR-T process evolution and meet manufacturing expansion requirements.
Support MES interfacing and new integrations with ERP, LIMS, OSI-PI, DMS, Data Lake, etc.
Update local MES documentation (SOPs, WIs, Technical/Design Specifications, and Test Protocols) with alignment to Global J&J Procedures.
Coordinate and execute MES Computer System Validation (CSV); including Commissioning Test Plans (CTP) Installation Qualification (IQ) and Operational Qualification (OQ), and Performance Qualification (PQ).
Serve as SME to lead and support MES related capital projects and site initiatives requiring manufacturing data.
Support quality investigations, deviations, and corrective & preventive actions in compliance to site procedures to ensure timely closure of records relative to MES.
Engage in the CAR-T site readiness of MES to support regulatory audits/inspections.
Qualifications Education.
Minimum of a Bachelor’s University Degree or equivalent is required; focused degree in Engineering, Information Technology, Computer Science or related field.
Experience and Skills.
Required.
Minimum 4 years of experience with eBR development and master data management in MES (PAS-X) within pharmaceutical and/or biotechnology manufacturing industry.
Direct experience with configuring MES interfaces (e.
., ERP, LIMS, OSI-PI Data Historian, Middleware, CMMS, DMS, LMS, QMS, Planning Software, and Scales).
Working knowledge of ISA-88 Standards for Process Control / ISA-95 Standards of Automated Interfaces, Good Manufacturing Practices (GxP and GAMP 5).
Working knowledge of MES Software Lifecycle Qualification, SDLC, Computer System Validation (CSV), and Data Integrity standards including FDA 21 CFR Part 11.
Experience supporting FDA and/or other Health Authority audits/inspections.
High affinity for Next-Gen MES Technologies and Cell Therapy Manufacturing Processes.
Excellent written and verbal communication expertise.
Preferred.
Familiar with Chain of Custody (CoC) and Chain of Identity (CoI) systems.
Understanding of process automation (Level 0-2); Equipment PLC, SCADA, and DCS.
Project Management Certification (e.
., PMP, Lean Six Sigma, or equivalent).
Experience working in a large highly-matrixed environment.
Other.
Requires up to 10% domestic and/or international travel.
The anticipated base pay range for this position is $ to $.
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.
areers.
nj.
om/employee-benefits.
This job posting is anticipated to close on April .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om 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.
areers.
nj.
om.