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Supply Chain Systems Lead Engineer, CAR-T Manufacturing MES
Raritan, NJ 08869 US
Engineering role focused on MES and other digital automations for manufacturing and supply chain. Expanding CAR-T facility. Highly visible role with excellent benefits! Apply today.
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, rapidly growing its manufacturing and laboratory capabilities. This position offers a perfect environment to understand CAR-T Cell Processing Manufacturing Operations and the underlying Supply Chain systems (Planning, Quality, Distribution, EHS, etc.), 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 NJ Cell Therapy facility scaling up operational flows to serve more patients and meet the highest quality standards without compromising manufacturing efficiency. This exciting new role works with the CAR-T Supply Chain Asset Management Lead and will be tasked with the expansion of current system capabilities with the goal to become a paper-less manufacturing facility.
The CAR-T SCS Lead is responsible for the design and implementation of CAR-T manufacturing (Level 2) systems (including MES, OSI-PI, and EMS) and support the scale-up of innovative cell therapy facilities in the NA region, through initial phase, network expansion, and steady state. In addition, they provide leadership in driving the execution of the multiple workstreams required to build and lead L2 systems content, including the electronic Batch Record (eBR) design of the clinical/commercial manufacturing operation in the North America region. Demonstrating a passion for data, the Lead will partner with CAR-T Digital / Data team, as well as Data Lake team to acquire business insights and propose data-driven solutions. This is an outstanding opportunity to sit on an E2E Supply Chain team and develop critical thinking & business experience. A fantastic role for a high potential talent seeking accelerated development.
- Lead and collaborate closely with Manufacturing Ops, Manufacturing Excellence, MSAT, Quality, partners and cross-functional teams through the projects' execution to ensure seamless delivery of cell therapy Manufacturing Execution Systems (MES)
- Lead automation projects' execution to achieve business goals, meet production schedules, and realize value; own timely delivery of project work, budget, resources, plan and documentation
- Strengthen the overall automation leadership and organizational capabilities
- Support the development of our Automation Network, Process Analytical Tools (PAT), Data Integrity (DI), Functional safety, and Cybersecurity
- Define Base Design for Master Batch Records and Recipe Structure in the MES system, supporting the process evolution to meet the expansion requirements
- Understand and optimize ERP related processes (MRP, warehousing, scheduling, Quality Release, etc.)
- Provide oversight for orchestration of Chain of Custody/Identity systems with manufacturing systems
- Participate in compliance inspections for topics related to manufacturing and/or supply chain systems
- Coordinate UAT Definition and Execution for Computer System Validation (CSV), and lead Integration testing (IQ) and Functional testing (OQ)
- Proficiently partner with external contract companies and suppliers
- Build, review, and manage site specific Work Instructions and execute against global SOPs (including back up, disaster recovery, user administration etc.)
- Provide (User) training to end users and system admins
- Support System Interface Specifications (SAP, eLIMS, Data Lake, OSI PI, etc.)
- Serve as SME to support various projects/initiatives requiring Manufacturing data
- Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Engineering, Information Technology, Industrial Automation, or related field preferred
Experience and Skills:
- Minimum 8 years of relevant work experience
- Experience with supply chain systems SAP, eLIMS, and PAS-X MES (or equivalent systems)
- Demonstrated experience managing or leading projects to support project delivery and operational readiness
- Experience implementing Process Automation Technologies
- Excellent written and verbal communication skills including experience writing procedures for a technical environment, documenting complex technical solutions, and communicate effectively with internal and external partners
- People leadership/management experience (direct or indirect reports)
- Working knowledge of one or more of the following automation systems/technologies: PLC, DeltaV Distributed Control System, OSi-PI Historian, PLC/SCADA, CMMS systems, OMP, Anaplan, and/or Tableau
- Working knowledge of Computer System Validation (CSV) and related data integrity standards
- Familiar with Chain of Custody and/or Chain of Identity systems
- Experience in actively participating in FDA or other Health Authority inspections
- Experience within the Pharmaceutical industry
- Experience within Manufacturing (GxP) environment
- Experience working in a large, highly-matrixed environment
- Project Management certification
- Requires up to 10% domestic and/or international travel
The anticipated base pay range for this position is $97,000 to $166,750.
Meet Your Recruiter
Vice President – Technical Recruiting, Skilled Labor, Accounting And Finance
Sean has over 8 years’ experience with Mattson Resources and over 20 years in executive search, technical recruiting, and staffing. With a Bachelor’s in Business Administration and a concentration in Human Resources as well as 16 years agency experience and 4 years corporate in staffing – Sean and his team can assist in all areas of search for your hiring needs. In agency search, Sean has led teams and recruiting services for Engineering, Sciences, IT, Skilled Labor, Operations, Supply Chain, Operational Excellence and more for Medical Device, Pharma, Aerospace, Automotive, Distribution, Transportation, IT Services, Software, Food & Beverage, Retail, and Consumer Products. In 2021 Sean oversaw Mattson Resources expansion and opening of a satellite office in Corona, CA.