Pas X MES SME/Solution Lead
12 months+ 12 months extension
4 days on site/1 day remote
English, Dutch is a big Bonus
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.
- 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.
- 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.