The MES Modelling Specialist plays a key role in supporting the standardized deployment of MES batch records across the MTO organization, as part of the NGM (Next Gen MES) Program.
Support the execution of NGM projects across MTO.
Business relationship management and ensuring the NGM program and best practices are meeting business requirements.
Provision of suitable training courses and training material.
Define SOPs for NGM enabling services.
Assure the safe execution of job activities and follow good environmental practices and procedures.
Ensure that personal training requirements are completed in compliance with site procedures.
Ensure that NGM documentation is managed, controlled, approved and reviewed in accordance with global procedures.
Develop and monitor Department metrics/KPIs to ensure that departmental goals and targets are met.
Drive efficiencies across the NGM program and site through suitable adoption of new technologies and enhanced approaches to how we operate (Challenge the Status Quo and drive improvement).

Requirements

Third level Degree in engineering, science or an IT discipline.
Five years plus of modelling experience within a pharmaceutical or GMP regulated manufacturing environment.
Technical knowledge of S95 Level 3 Electronic Batch systems such as Werum MES PAS-X.
Good understanding of S95 level 4 systems and their capabilities such as ERP, Quality Systems, Data warehouses etc., to facilitate the transition to integrated Systems within the batch record.
Strong process knowledge for Drug Substance or Drug Product Manufacturing.
Understanding of the ISA S95 & S88 standards and how they should be used within the Global Supply Chain.
Good appreciation of Industry 4.0/IIoT and how we can effectively drive to transform within this framework.

Benefits

Health insurance
401(k) matching
Flexible work hours
Paid time off
Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

modelling experienceS95 Level 3 Electronic Batch systemsWerum MES PAS-XS95 level 4 systemsERPQuality SystemsData warehousesprocess knowledge for Drug Substance Manufacturingprocess knowledge for Drug Product ManufacturingISA S95 & S88 standards

Soft Skills

business relationship managementtraining provisiondocumentation managementefficiency drivingimprovement driving

Certifications

Third level Degree in engineeringThird level Degree in scienceThird level Degree in IT discipline