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Pas X MES SME/Solution Lead

  • Ubicación:

    Gante, Bélgica

  • Contacto:

    Michael Rownicki

  • Tipo de trabajo:

    Contract

  • Teléfono de contacto:

    +353 21 485 7227

  • Industrias:

    Life Sciences

  • Correo de contacto:

    michael_rownicki@oxfordcorp.com

OXFORD OPPORTUNITY

Pas X MES SME/Solution Lead

Client industry:

BioPharma

Schedule:

100%

Position:

MES SME/Lead

Location:

Ghent, Belgium

Start date:

ASAP

LOA:

12 months+ 12 months extension

On site/remote:

4 days on site/1 day remote

Languages:

English, Dutch is a big Bonus

PROJECT DESCRIPTION

The construction and operational readiness of the CAR-t facility in Belgium is part of the global CAR-T program for multiple myeloma, a disease affecting ~160,000 patients annually. The CAR-T represents the next generation transformational therapy for multiple myeloma.

The MES Werum Pass X implementation group needs to onboard an MES Expert Solution lead to take over the set up, implementation and configuration of this for the new greenfield site.

Daily Tasks

  • Support the End-to-End delivery of major Manufacturing application and platform development and support Services.
  • Identify optimization opportunities and execute to result in reduced Total cost of ownership while maintain established Service Levels. Establish standard processes.
  • Lead extended, global, enterprise teams of internal and external professionals.
  • Take the lead in implementation and configuration of MES Pas X
  • Ensure execution excellence in the delivery of team and project objectives.
  • Ensure IT compliance (WICO, HIPAA, GXP, 21 CFR Part 11, WICO, Records Management, SOX, SDLC, CSV) requirements in all activities and solutions.
  • Assist in the delivery of application development and support services for Global and Regional and site-based MES systems, ensuring quality and timely delivery of services to consumers.
  • Assist in support and delivery for existing manufacturing systems to ensure sites operate to business needs and issues are resolved as they arise.
  • Provide innovative ways of problem solving and implementing system improvements.
  • Act as subject matter expert on technical architectures and service platforms.

Skills/Background

  • 4 -5 years' minimum experience supporting Supply Chain/Manufacturing Systems required.
  • Werum Pass X experience is a must
  • Minimum BS/BA in Computer Science or equivalent.
  • Experience in a matrixed environment and leading support teams is required.
  • Training with certification (Green or Black Belt) in Process and/or Design Excellence is a plus.
  • Experience with Weighing scales, label printers etc and SAP is a plus
  • Training in Process Mapping and Design preferred.
  • Working knowledge of IT Service Management frameworks including but not limited to ITIL preferred.
  • Experience in application development and support required.
  • Experience in project management and delivery with benefits delivered as committed preferred.
  • Experience in GxP systems, Computer System Validation and consistent track record in the support of FDA regulated systems and business preferred.
  • Strong interpersonal skills required. Excellent communication, networking, and influencing skills including the ability to manage across all management and organizational levels.