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Senior Manufacturing Systems Engineer, PAS-X MES
Raritan, NJ 08869 US
Great Benefits - Base, Annual Bonus, Pension, world class medical, dental, vision - all new hires start with upwards of 28 days vacation, holidays and PTO!
One of the world's most admired companies is looking to hire MES Engineers as they scale up manufacturing for CAR-T Cell Therapy manufacturing! This exciting new role works with the CAR-T Supply Chain Systems Lead and will be tasked with the expansion of current system capabilities and will be tasked with the design, plan, and implementation of multiple electronic Batch Records with the goal to become a paper-less manufacturing facility.
The Senior Engineer should be passionate about Data and will work together with Data Lake teams to acquire business insights and propose data-driven solutions. All Batch Record modelling will be done in the latest PAS-X MES software (v3.3); any prior experience will be preferred, though basic training will be available for a candidate who shows strong willingness to master this critical manufacturing software tool. 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.
- Collaborate closely with Manufacturing Ops, Manufacturing Excellence, MSAT, Quality, and cross-functional teams through the projects' execution to ensure seamless delivery of cell therapy Manufacturing Execution Systems (MES)
- Define Base Design for Master Batch Records and Recipe Structure in the MES system, supporting the process evolution to meet the expansion requirements
- Creation of Master Batch Records including MBR Modelling
- Participate in compliance inspections for topics related to manufacturing systems
- Coordinate UAT Definition and Execution for Computer System Validation (CSV), and lead Integration testing (IQ) and Functional testing (OQ)
- 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 (Operations and Operations Support)
- Support System Integration (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 4 years of relevant work experience
- Experience with supply chain systems SAP, eLIMS, and PAS-X MES (or equivalent systems)
- Experience with Manufacturing Processes (GxP) and related Master Data Management
- High affinity for New Technologies and Processes
- 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
- 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 working in a large, highly-matrixed environment
- Project Management certification
The anticipated base pay range for this position is $73,000 to $117,300.
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.