Subject Matter Expert

Major accountabilities: 

• Oversees the development, testing, and implementation of the technical solution, and validates the final product satisfies the defined requirements.
• Reviews technical documentation, such as user guides, training manuals, and system specifications, prior to distribution to end-users, and ensures their subject area is accurately represented.
• Ensure that local SOPs related to his area of expertise, will be aligned to HSE, GMP, Regulatory and company requirements and policies will follow TPM approach.
• Cultivates and maintains effective working relationships with a variety of stakeholders, including end-users, project managers, engineers, QA, MS&T and senior staff members.
• Support the continuous improvement trough a risk based approach, using specific tools like FMEA/FMECA RRCI RCA, for new projects and life cycle management of existent equipment.
• Serialization and aggregation tasks.
• Supervise maintenance / calibration work as Subject Matter Expert (SME).
• Maintenance and calibration activities (preparing tools, identifying spare parts, executing work orders etc).

Essential requirements:

• Scientific or Engineering degree.
• Previous experience in a similar role within a GMP manufacturing site.
• Fluent in Italian. Good knowledge of English.
• Experience in system testing and business processes. SAP knowledge.
• Able to work in a global matrix environment.