PASX MES Engineer — Pharma 4.0 Implementation Lead
Cognizant Life Sciences Manufacturing
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Descrizione del lavoro
Cognizant Life Sciences Manufacturing in Napoli, Italy is seeking an experienced MES specialist to lead end-to-end MES implementations, especially PASX design and validation. The role focuses on delivering compliant, scalable MES solutions aligned with GMP and Pharma/Biotech requirements.
The ideal candidate will drive system governance, data modeling, and eBR authoring across multi-site deployments, ensuring timely delivery and adherence to regulatory standards.
Competenze
- Multiple years of MES experience, specifically with MBR design in PasX.
- Hands-on experience with deployment of MES.
- Strong knowledge of ISA-88/ISA-95 standards, GMP regulations, and MES best practices.
Mansioni
- Lead and manage MES implementation phases including design, configuration, validation, deployment, and support.
- Translate business requirements into PASX system design and functional specifications.
- Provide governance over PASX object modeling, system integration and recipe life cycle management.
- Conduct project planning, risk management, and progress tracking aligned with GxP and project goals.
- Serve as technical advisor for CRs, GMP readiness, and MES operational strategies.
- Create data and equipment model for implementation of MES functionalities.
- Author and configure MES eBRs
- Development and update of SOPs.
- Test, validate and demonstrate eBRs. Post go-live support
Conoscenze
Formazione
Strumenti
Descrizione del lavoro
Cognizant Life Sciences Manufacturing in Napoli, Italy is seeking an experienced MES specialist to lead end-to-end MES implementations, especially PASX design and validation. The role focuses on delivering compliant, scalable MES solutions aligned with GMP and Pharma/Biotech requirements.
The ideal candidate will drive system governance, data modeling, and eBR authoring across multi-site deployments, ensuring timely delivery and adherence to regulatory standards.
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