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.
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