- Must have exposure to the Life Sciences industry mainly in the following areas:
- Medical products and devices
- Experience in providing services such as large-scale business and technology transformation, targeted business performance improvement and post-merger integration for R&D functions (includes Pharmacovigilance, Clinical, Regulatory, Pre-clinical and research, QC and research laboratories).
- Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements.
- Profound experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing and Quality space (e.g. ERP/SAP, CTMS, MES, LIMS)
- Excellent background and experience in project management of large global IT projects
- Extensive track record of successful cross-divisional / cross-functional work with complex international and multidisciplinary teams
Assist with the translation of business requirements into technical requirements
Coordinate and lead design initiatives and reviews with developers
Translate selected designs into detailed tasks, dependencies, and estimates
Coordinate and lead code reviews
Manage project schedules and provide technical leadership and mentoring to support developers
Monitor, encourages and enhances best practices in development and methodology
Communicate and enforce coding standards
Assume hands-on ownership for the most pressing technical tasks and issues
Responsible for build generation and implementation
Impact analysis and successful implementation and configuration of the system
Experience includes the development of GUI, Workflows, Phase, Equipment management, Equipment management with run-time properties, Labels and Reports using Jasper reports, Use-cases, Flexible state model, EIG transaction, LIMS integration and Data Migration used in MES solutions
Deployment experience with plant floor/Manufacturing Execution Systems (MES) solutions (e.g. Rockwell ProPack Data, Werum PAS-X, POMS) is a must.
Knowledge of SAP Material Master (MM), Production Planning (PP), Production Planning for the Process Industry (PP/PI) and Quality Management (QM) modules is highly preferred.
Experience with FactoryTalk Production Centre, PharmaSuite, LabWare LIMS, and PI-Historian is highly desirable. Automation Software experience with RSLogix 5000, FactoryTalk® Batch PlantPAx are helpful. Also, Experience with .NET technologies preferred
Knowledge of FDA, EU, and global GMP's including Good Automated Manufacturing Practices, 21 CFR Part 11, and EU cGMP Annex 11. Relevant Quality education or training within ISO 9001 and cGMP is highly preferred.
Validation experience in the Life Science / Pharmaceutical industry required. Ensure that the system remains in a validated state and that proper change control practices are followed (CCRs, documents updates....etc.). The MES Engineer will also act as the primary contact for Regulatory Compliance internal and external audits.
Experience integrating ANSI/ISA-88 and ANSI/ISA-95 standards where the MES is integrated into the Batch Execution System (BES)