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US Tech Solutions
Jersey City, NJ
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Job Description :
Position Summary and Prerequisites:
Reporting into the IT organization the candidate will be primarily responsible for driving solutions to manufacturing system related problems including reviewing, planning, building, testing, documenting, and implementing design changes. The candidate should have at least 10 years of experience in pharma/biotech with specific expertise in Supply Chain, Manufacturing, and Quality System disciplines. The applicant needs to have a strong grasp on shop floor activities, Good Manufacturing Practices (GMPs), and process automation in addition to prior experience both in Manufacturing Execution System (MES) implementation and corresponding Enterprise Resource Planning (ERP) system integrations.

Responsibilities will include, but are not limited to the following:
Collaborate with business stakeholders and implementation partner(s) to configure, build, and deploy the MES system.
Collaborate with business process leads to design master data, recipes, etc.
Accountable for operationalizing the MES and peripheral systems.
Act as a site lead for the support of MES system.
Accountable for uninterrupted 24/7 operation of manufacturing systems for CAR-T manufacturing.
Understanding of the concepts around traceability, Chain of Identity (COI), Chain of Custody (COC), Chain of Condition, etc. for the supply chain of personalized medicine.
Assist the leadership team with establishing a support organization and Service Level Agreements (SLAs
Manage daily operation and future enhancements of MES and lower level systems as an IT system owner and technical expert.
Participate in global harmonization of MES implementations, equipment/process and instrument interfaces.

Required Background/Knowledge:
Bachelor’s degree in an engineering or MIS discipline (advanced degree is preferred)
Must have experience with Tier-1 MES, preferably Emerson Syncade, in a bio-tech manufacturing environment.
Must have 8 to 12 years of hands-on experience in a biotech manufacturing and supply chain environment
Hands-on experience in designing, building and supporting interfaces between ERP, Quality, MES and shop-floor boundary systems.
Solid knowledge of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP
Strong working knowledge and accountability of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
Sound understanding of Electronic Batch Records (EBR) and Review by Exceptions (RBE
Must have prior experience working on a project team to implement, customize, or enhance an MES system.
Experience with business process re-engineering, including documenting workflows and developing functional specifications.
Familiarity with Business Intelligence (BI) and reporting programs including OBIEE or similar tools.
Understanding of computer system validation.
Additional Skills/Knowledge:
Understand modern manufacturing concepts like smart factory and shop floor automations.
Global implementation experience at multiple sites and products.
Advanced written and oral communication capabilities.
Must be a team player who collaborates with multiple business streams.
Management & Interpersonal Skills:
Excellent interpersonal skills, especially regarding:
Teamwork and collaboration
Client focus
Verbal and written communication
Strategic thinking
Results driven
Change and innovation
Leadership