
Architect - MES Solution
- Sesto Fiorentino, Firenze
- Tempo indeterminato
- Full time
- Act as the process-specific design lead for Electronic Manufacturing Batch Records (MBRs), ensuring alignment with both global standards and site-specific requirements.
- Lead the design and configuration of MBRs for a given manufacturing or packaging process, collaborating closely with site teams and global Subject Matter Experts (SMEs).
- Identify synergies across manufacturing sites to drive harmonization and promote reuse of MBR components.
- Define and maintain clear boundaries between Global MBR content and Site-specific localization to ensure standardization and flexibility.
- Ensure that MBR designs reflect compliant, efficient, and scalable manufacturing processes.
- Collaborate with cross-functional teams (Technical Service /Manufacturing Science, Process Engineering, QA, IT) to gather process requirements and translate them into MES functional design.
- Serve as the main point of contact for MBR-related topics during NG MES deployments, from initial scoping to validation.
- Contribute to the creation and governance of Global Design Templates and Configuration Standards for MES.
- Provide guidance and coaching to local teams during MBR design and testing activities.
- Continuously improve the design process by incorporating lessons learned and best practices from prior deployments.
- Education: Bachelor’s Degree in IT, Computer Science, Engineering, or equivalent years of experience.
- Minimum 7 years as an IT Business Integrator or IT Project Leader in Life Science Manufacturing.
- Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11).
- Familiarity with MES platforms such as PharmaSuite (preferred), PMX, Werum PAS-X, Emerson Syncade, DeltaV or similar is strongly preferred.
- Ability to work cross-functionally and communicate effectively with technical and non-technical stakeholders.
- Proficiency in English (written and spoken).
- Experience working globally, influencing without authority, and resolving complex issues.
- Learning agility, subject matter expertise in Life Sciences.
- Knowledge of Business Process development, SOPs, Governance Processes, and Program Management.
- Risk-based decision making, diverse communication methods, and strong account management skills.
- Position locations: Indianapolis, Charlotte, Raleigh-Durham, Kenosha, Puerto Rico, Alcobendas, Fegersheim, Alzey, Sesto
- Occasional off-hours and weekend work expected.
- 10-15% domestic/international travel required.