Summary
Responsible for Engineering activities including planning and coordination of maintenance & calibration activities, project execution and continuous improvement at site level (e.g. buildings, process equipment, utilities, automation).
About the Role
- Strategy & Organizational Development
- Ensures equipment operates to required HSE, Quality, Environmental and Reliability standards
- Lead or contribute to equipment, utility, facility improvement projects (e.g. energy efficiency, productivity, environmental compliance, maintenance)
- Support internal and external audits
- Implement GOPs
- If needed, create regional / site SOPs & templates
- Own the Training Curriculum for own Job Profile
- Train operators and / or technicians
- Manage maintenance improvement projects and initiatives (local or corporate)
- Establish maintenance & calibration plan content
- Enter master data into CMMS (e.g. confirmation and technician time allocations)
- Coordinate maintenance / calibration activities
- Plan resources for maintenance / calibration
- Allocate work for maintenance / calibration to technicians
- Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI)
- Enter work orders into CMMS for maintenance / calibration
- Develop method statement for maintenance / calibration
- Perform risk assessment for maintenance / calibration
- Provide frontline support for technicians
- Supervise maintenance / calibration work
- Assess quality impact and release after maintenance
- Assess equipment fit for purpose
- Set-up maintenance for new equipment (incl. spare part needs)
- Develop, monitor and improve KPI for maintenance & calibration
- Execute FMEA and define the maintenance type for each asset; assess equipment criticality (HML)
- Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request
- Investigate deviations (Root Cause Analysis)
- Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets)
- Plan spare parts (order spare parts, manage master data, minimum order quantity, documentation)
- Manage stores for spare parts (good receipt, incoming inspection, delivery to work area, make parts for quick repairs and improvements)
- Establish vendor contract
- Identify technical solutions
- Prepare Equipment Specifications and System Requirements in project (e.g. User Requirement Specification)
- Prepare, review and approve drawings, lists, schedules, diagrams, layouts, calculations and datasheets in project
- Develop project turn over plan
- Perform new equipment FAT / SAT / inspections in project
- Perform commission activities
- Manage project deficiencies and deviations
- Perform provisional and final project handover
- Provide technical trouble shooting during PQ and validation
- Develop periodic requalification plan
- Execute periodic requalification plan
- Develop & implement Coding / Recipes (DCS / Scada / PLC's / Control Networks)
- Monitor Automation (DCS / Scada / PLC's / Control Networks hardware)
- Design, implement & maintain Historian Configuration for modules / visualization / OPEX
- Implement Software Change Controls associated with automation / system changes
- Design and implement Master Batch Records (MBR) for MES
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Division: International
Business Unit: Innovative Medicines
Location: Italy
Site: Ivrea
Company / Legal Entity: IT58 (FCRS = IT058) AAA Italy Srl.
Functional Area: Technical Operations
Job Type: Full time
Employment Type: Regular
Shift Work: No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.