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Consultant and Manager, IT & Automation

  • Profile Created:
  • 4 months ago

Skills

Education

Experience

  • Current Company 2019 - Present

    CONSULTANT AND MANAGER, IT & AUTOMATION

    Medical Devices: - Project manager for development team - Project manager for process transition and change project - Establishing new organisation and processes to handle new product development - Regulatory Affairs MDR transition detailed project planning incl. workshops - MDR project support and management support incl. detailed planning workshops etc. - Corporate Quality Strategy targets and KPI’s - Corporate Quality masterplan (insight into resources, deadlines, deliveries, etc.) Medicinal Cannabis and Laboratory: - Inspection readiness assessment of IT - Validation of software used for laboratory equipment Pharmaceutical: - Data Mapping of production preparing for artificial intelligence (AI) - Proff of Concept project utilizing existing data through AI for optimization of 4 production processes

  • Large pharmaceutical company: 2016 - 2019

    PROJECT MANAGER, AUTOMATION AND IT PROJECT MANAGEMENT

    • Facility 1: - Change Process Control System from PLC to PCS incl. instrumentation, electrical and mechanical upgrade - Quality agreements with suppliers - Facility project coordination with other shutdown projects • Facility 2: - Responsible for all IT & Automation projects and personal working in portfolio - Rebuild of purification facility - Multi receipt handling and computer software validation issues - Installation of new fully automated CIP stations • Facility 3: - Start up and organization structure for plant rebuild to multiple products on same line and with same validated software

  • Large pharmaceutical company 2014 - 2016

    LEAD AUTOMATION ENGINEER, PROCESS AUTOMATION

    • Facility 1: - Responsible for all IT & Automation projects and personal working in portfolio - Change Process Control System from PLC to PCS - IT Virtualization of process control systems - Rebuild of purification facility - GAP analysis (‘As-specified’ compared to ‘As-is’) - Multi receipt handling and computer software validation issues - Installation of new fully automated CIP stations - Review of validation documentation - Validation and qualification of PCS system - Ensuring cross-disciplinary coordination and interfaces - Training of key personal • Facility 2: - Bioreactors and utility for pilot plant incl. upgrade of IT interface - Validation and qualification of PCS system - Production ramp-up - Training of key personal

  • Large pharmaceutical company 2013 - 2014

    AUTOMATION ENGINEER

    - Rebuild of purification facility - GAP analysis (‘As-specified’ compared to ‘As-is’) - Multi receipt handling and computer software validation issues - Programming and validation of new fully automated CIP station - Training of key personal