Intro to Automation & ITdau.dk/Content/file_knowledge_item/DAu_Intro_to... · 2017. 10. 31. · Ingeniøruddannlese inden for Automation i Danmark (2004) Specified by the Automation

Introduction to Automation & ITwith focus on Competences

DAu Seminar2017-10-25

Presented by Leif PoulsenGlobal Technology Partner, NNE

Automation & IT - Copyright 2017 NNE A/S1

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

3

2,000professionals

18Office locations

worldwide

40%

new productionfacilities

30%

pharmaconsulting

30%

restructuring andfacility upgrades

An international companyspecialised in pharma engineering

We bring best practicesto our customers

We are supporting our customers globally and on local sites

We enable pharma companiesto deliver on demand

3,000projects globally / year

About NNE

Automation & IT - Copyright 2017 NNE A/S

Automation & IT Organisation


Automation

& IT

Consulting

Automation

Solutions

Automation

& IT

Project

Management

Manu-

facturing

IT

Solutions

Quality &

Compliance

Customer

Service

Operations

+300 people

+200 projects

Automation & IT Services at a Glance


Conceptualize Plan Build Operate

Front End Eng./

Basic engineering

Service&

Support

Project

execution

Finished Pharma

Project

execution

MES

Project

execution

API

Automation/IT

Strategy

Conceptual

Design

Life cycle

planning

Optimization

services

Go

Live

Project management

Automation & IT Approach - Best Practices


Proven

Technology

& Standards

Flexible

Solutions/

Modular

Engineering

Pro-active

Project

ManagementRisk Based

Validation

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)

Process

Understanding

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


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


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

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

Process Control (PCS)

Resource Planning (ERP)

Manufacturing Execution System (MES)

Sp

ecific

atio

n

Reso

urces

Execu

tion

Qu

ality

Do

cu

men

tatio

n

Op

timis

atio

n

Automation & IT Competence Requirements


General Requirements

• Collaboration

• Communication

• Languages

• Flexibility/Mobility

• Business Understanding

• Creativity

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

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)

Automation & IT Competence Profiles


0

200

400

600

800

1.000

1.200

Instru

men

tatio

n Eng

inee

ring

Electric

al E

nginee

ring

Pro

cess

Con

trol &

Mon

itorin

g Sys

tem

s

Gen

eral A

utom

ation

Disciplines

Gen

eral IT

Disciplines

Aut

omat

ion

Pro

ject M

anag

emen

t/Con

sulting

Qua

lity M

anag

emen

t

Aut

omat

ion

Eng

inee

ring

Pro

cess

Sta

ndar

d Ana

lysis, D

esign

& Pro

gram

ming

Tools

Sta

ndar

ds &

Guide

lines

Mat

erial &

Pro

cess

Kno

w-H

ow

Pro

duction

Ana

lysis & C

ontro

l Prin

ciples

Mod

ular

Eng

iner

ing

Competencies

Le

ve

l in

ho

urs

Post Education

Special Education

Basic Education

Specified by DAu:

Ingeniøruddannlese inden for Automation i Danmark (2004)

Specified by the Automation Federation in USA:

https://www.automationfederation.org/Focus/WorkforceDev

https://www.automationfederation.org/Focus/WorkforceDev

Automation & IT Competence Levels


Experts

setting the standards

Professionals working on their own

Internal Development of Talents

Graduates working with guidance from others

Masters coaching/training others

Automation & IT - Competence Development


Competence

Strategy

Competence

Development

Plans

Recruitment

Plan

Project

Staffing

Personal

Development

Plan

Rotation

Plan

Introduction

Plan

Business

Strategy

Business

Plans

Automation & IT - Competence System

15

• 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


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


Automation & IT - Learning Model

17

70% Experience

20% Exposure

10% Education

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

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

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


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

Automation & IT - Industrial Trends


Business & Operation Trends: Manufacturing Technology Trends:

• Globalisation/Off-

shoring/Outsourcing

• Cost Reduction/Operational

Excellence

• Personalised Drugs & Smart

Delivery Systems

• Agile & Flexible Manufacturing

• Sustainability & Environment

• Single Use Technology

• Closed Systems

• Continuous Manufacturing

• Collaborative Robots

• 3D Printing

Quality & Compliance Trends: 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

Documents

Intro to Automation & ITdau.dk/Content/file_knowledge_item/DAu_Intro_to... · 2017. 10. 31. · Ingeniøruddannlese inden for Automation i Danmark (2004) Specified by the Automation