Presented by Leif Poulsen Global Technology Partner, NNE Introduction to Automation & IT with focus on Competences DAu Seminar
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1 Presented by Leif Poulsen Global Technology Partner, NNE Introduction to Automation & IT with focus on Competences DAu Seminar
2 Agenda Automation & IT Organisation Automation & IT Services Automation & IT Best Practices Automation & IT Project Examples Automation & IT Competence Requirements Automation & IT Competence Profiles Automation & IT Competence Development Automation & IT Industrial Trends 2
3 About NNE An international company specialised in pharma engineering We bring best practices to our customers 3,000 projects globally / year We are supporting our customers globally and on local sites 30% pharma consulting 30% restructuring and facility upgrades 40% new production facilities 2, professionals Office locations worldwide We enable pharma companies to deliver on demand 3
4 Automation & IT Organisation Automation Solutions Manufacturing IT Solutions Automation & IT Consulting Quality & Compliance +300 people +200 projects Customer Service Operations Automation & IT Project Management 4
5 Automation & IT Services at a Glance Conceptualize Plan Build Operate Project management Automation/IT Strategy Project execution API Service& Support Conceptual Design Front End Eng./ Basic engineering Project execution Finished Pharma Go Live Life cycle planning Project execution MES Optimization services 5
6 Automation & IT Approach - Best Practices Recognized Standards & Guidelines: Computer Validation (GAMP5) Systems Compliance (e.g. 21CFR11) Plant Integration (ISA S95.01 & 02) Batch Control (S88.01 & 02) Interfaces (OPC, B2MML) Control System Security (ISA S99) Fieldbuses (IEC 61158) Barcodes (GS1) Proven Technology & Standards Flexible Solutions/ Modular Engineering Process Understanding Pro-active Project Management Risk Based Validation 6
7 Typical Automation Solutions Recipe & Batch Management/Reporting Process Control Systems (DCS/SCADA/PLC) Process Monitoring & Alarm Handling Data Collection & Visualization (Historian) Advanced Control & Optimization Performance Monitoring (OEE) Process Analytical Technology (PAT) Cleaning & Sterilization (CIP/SIP) Facility Monitoring Systems (FMS) Building Management Systems (BMS) Process Instrumentation & Networks Typical project deliveries: Instrumentation Control System HW Standard software and licenses Specifications & Design Programming & Test Installation & Commissioning Qualification (IQ/OQ/PQ-support) Training & Ramp-up support 7
8 Typical Manufacturing IT Solutions Manufacturing Execution Systems (MES) Master Data Management (BOM, MR, SOP) Resource Management (Personnel, Equip., Material) Production Scheduling & Execution Electronic Batch Documentation (EBR, EDM) Data Collection & Analysis (Historian, KPI, OEE) Business Intelligence (Data Warehouses) Automated Material & Warehouse Management Automated Product Tracking (RFID, epedigree) Laboratory Automation & LIMS System Infrastructures & Integration 8
9 Automation Project Example New Omega-3 Bulk Facility (API) Complex batch process (S88 Design) High level of automation Distributed Control System (DCS) Integrated with Historian & Batch Reporting Completed on budget 6 weeks before schedule Awarded at Emerson Exchange NNE Role: Main contractor 9
10 Optimisation Documentation Quality Execution Resources Specification Manufacturing IT Project Example MES System Roll-Out Formulation, Filling, Assembly & Packaging Global roll-out of MES System Integration with ERP & PCS Project Characteristics: Large project/high complexity Integration wit many different systems Harmonization/alignment of many different business processes NNE Role: Consultant on MES & System Integration & Training Resource Planning (ERP) Manufacturing Execution System (MES) Process Control (PCS) 10
11 Automation & IT Competence Requirements General Requirements Collaboration Communication Languages Flexibility/Mobility Business Understanding Creativity Basic Technical Education: Basic technical education within engineering and information technology Special technical skills like programming, databases, and visualisation techniques Cross disciplinary skills like project management, quality, safety & environment Training in collaboration/team work (projects) Knowledge management (ability to maintain knowledge and create knowledge networks) Specializations/Post-graduate training: Automation theory/methods Instrumentation & electro techniques Process control & supervision Information Technology Engineering/Project Work Project Management Consulting Skills Quality Assurance Standard Tools & Technologies Standards & Guidelines Process Knowledge 11
12 Automation & IT Competence Profiles Level in hours Post Education Special Education Basic Education Instrumentation Engineering General Automation Disciplines Electrical Engineering Process Control & Monitoring Systems General IT Disciplines Automation Project Management/Consulting Standards & Guidelines Quality Management Automation Engineering Process Standard Analysis, Design & Programming Tools Competencies Material & Process Know-How Production Analysis & Control Principles Modular Enginering Specified by DAu: Ingeniøruddannlese inden for Automation i Danmark (2004) Specified by the Automation Federation in USA: 12
13 Automation & IT Competence Levels Experts setting the standards Masters coaching/training others Professionals working on their own Graduates working with guidance from others Internal Development of Talents 13
14 Automation & IT - Competence Development Business Strategy Competence Strategy Business Plans Competence Development Plans Recruitment Plan Introduction Plan Rotation Plan Project Staffing Personal Development Plan 14
15 Automation & IT - Competence System Our Competence Management System is developed to facilitate the competence management process in NNE Overview of competences & responsibilities Overview of individual competences Overview of competence targets, status & gaps 15
16 Automation & IT - Communities of Interests (COI) A COI is a global community of people who share a common interest or passion. The Global COIs have industry insight and are at the forefront of their profession. They are the backbone of our global core competencies and they exchange best practice, obtain answers to problems and are responsible for our knowledge base. In NNE we have established 25 COI s, 3 within Automation & IT 16
17 Automation & IT - Learning Model 70% Experience Work Based Learning: Project work Visit customers and sites Job rotation Greater responsibility Internal development projects Interaction with colleagues Collaboration on new tasks Share knowledge Global Exchange Programme COI work 20% Exposure Network: Mentoring and coaching Feedback from peers, specialist or manager Scheduling interviews with specialist Shadow a high performer COI network Senior/Junior partnership External activities ISPE Professional network Leadership network Pharma- and Biotech network Giving lectures Writing articles Online Blogs and social media 10% Education Courses Our Academy PEAK External courses Technical skills Personal skills Business understanding E-learning Conferences and Seminars ISPE Technical conferences Pharma and Biotech Fairs and exhibitions Continued / Higher Education Bachelor or Master degree Certificates 17
18 Automation & IT - Academy & Training Program (PEAK) Our Academy is the forum for developing our competencies in NNE. In addition to formal training courses, the training platform offers a number of seminars where we exchange information across the organisation. The seminars are a collection of e-learning, short classroom presentations held by our specialists, and full day seminars providing more details. PEAK is our global competency development programme (Pharma Engineering Advanced Know-how) With PEAK we want our pharma engineers to accelerate their knowledge and to become thought leaders within their field of expertise - and to contribute to making NNE the most exciting place to work in the industry. Examples of topics within Automation & IT Automation & IT Basic Course Automation & IT SME course Automation & IT Advanced Course (Industry 4.0) IT Compliance courses: Computer validation Computer Quality Management Data Integrity Risk Management ART Tool SLA Management Good Operational Test Practice S88 Batch Control S95 Enterprise Control System Integration 18
19 Automation & IT - Industrial Trends Business & Operation Trends: Manufacturing Technology Trends: Globalisation/Offshoring/Outsourcing Cost Reduction/Operational Excellence Personalised Drugs & Smart Delivery Systems Agile & Flexible Manufacturing Sustainability & Environment Quality & Compliance Trends: Single Use Technology Closed Systems Continuous Manufacturing Collaborative Robots 3D Printing Automation Technology Trends: Paperless Manufacturing QbD & Control Strategy Continued Process Verification Global Material Tracking & Product Serialization Data Integrity Cyber Security Life Cycle Management Virtualisation and Cloud Computing Intelligent Devices and Internet of Things Augmented/Mixed Reality 19
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Robbie Morehead Project Manager
Profile The consultant is an accomplished quality professional with 27 years' extensive medical device, pharmaceutical, regulatory, and Food and Drug Administration (FDA) experience. The consultant s experience
Role Description Confident people working together for our future
Role Description Confident people working together for our future Role details Position title: Program Manager - Regulatory Improvement Position number: EPA600690 Reports to: Manager Regulatory Programs