Solution Architect, Manufacturing Execution Systems
Company: Mitchell Martin
Location: New Brunswick
Posted on: February 15, 2021
Our client, a pharmaceutical company, is seeking a Solution
Architect, Manufacturing Execution Systems
Location: New Brunswick, NJ
Position Type: Contract
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
Responsibilities will include, but are not limited to the
-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,
-Accountable for operationalizing the MES and peripheral
-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.
-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
-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.
-Understand modern manufacturing concepts like smart factory and
shop floor automations.
-Global implementation experience at multiple sites and
-Advanced written and oral communication capabilities.
-Must be a team player who collaborates with multiple business
-Management & Interpersonal Skills:
-Excellent interpersonal skills, especially regarding:
-Teamwork and collaboration
-Verbal and written communication
-Change and innovation
Keywords: Mitchell Martin, New Brunswick , Solution Architect, Manufacturing Execution Systems, Other , New Brunswick, New Jersey
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