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BioPharmaEngineeringireland2016

Excellence in Pharmaceutical & Biotech Plant Design, Engineering & Construction Conference & Partnering Event

13th & 14th April 2016 | CORK, IRELAND

Enterprise Ireland is the Irish state development agency focused on transforming Irish industry. Our core mission is to accelerate the development of world-class Irish companies to achieve strong positions in global markets resulting in increased national and regional prosperity. We work closely with International companies to identify and introduce them to Irish suppliers who can best meet their needs.

Ireland is a key location for the global healthcare industry. Thirteen of the top fifteen companies in the world have substantial operational bases in Ireland.

This biopharmaceutical cluster is supported by a sophisticated infrastructure of serviced sites and public utilities as well as a network of specialist support companies and services.

The following directory showcases a selection of Irish companies supplying the Biotech, Pharmaceuticals, and Life Sciences industries in Ireland and internationally.

Index

Ardmac ................................................................................................................ 1

BCD ...................................................................................................................... 2

Bruce Shaw .......................................................................................................... 3

Callaghan Engineering ......................................................................................... 4

ClearSphere ......................................................................................................... 5

Collen Construction ............................................................................................. 6

Cora Systems ....................................................................................................... 7

Dornan Engineering ............................................................................................. 8

EIDA Solutions...................................................................................................... 9

Enterprise System Partners ................................................................................10

Flow Technology .................................................................................................11

Hal Software .......................................................................................................12

Hanley Energy .....................................................................................................13

Horizon ...............................................................................................................14

John Paul Construction .......................................................................................15

John Sisk & Son ...................................................................................................16

Jones Engineering Group ....................................................................................17

Kirby Group Engineering .....................................................................................18

Kneat Solutions ...................................................................................................19

KPC International ................................................................................................20

Life Science Consultants .....................................................................................21

Mercury Engineering ..........................................................................................22

MSL Engineering .................................................................................................23

NIBRT ..................................................................................................................24

OEEsystems International ...................................................................................25

PanelDuct®..........................................................................................................26

P.J. Hegarty & Sons .............................................................................................27

PM Group ...........................................................................................................28

Premium Power ..................................................................................................29

Prochem Engineering ..........................................................................................30

PRO Stainless Designs .........................................................................................31

ProSys Containment & Sampling Technology .....................................................32

Radley Engineering .............................................................................................33

Winthrop Engineering & Contracting ..................................................................34

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George Walker george.walker@ardmac.com Tel: +353 (0) 189 48800

Swords Business Campus, Swords, Co. Dublin, Ireland www.ardmac.com

Ardmac Ardmac is an international cleanroom construction company specialising in the construction of high value technical environments for market-leading corporations.

Operating through our office network across Ireland, the UK and the Benelux region, with business partnerships in the USA and Asia, we work with engineering consultancies and clients to provide architectural and turnkey solutions to cleanroom and controlled environments.

Our in depth knowledge of client processes gives us the ability to interpret out clients’ requirements and provide the best technical and value engineered solution to meet their needs. We have built up a strong international customer base by exceeding in the project critical areas of safety, design, quality, cost, scheduling and co-ordination, giving our clients that certainty and reassurance that they can meet their market commitments.

Ardmac’s architectural cleanroom solutions include traditional drywall and applied epoxy coatings together with first and second generation modular systems, designed to meet the maximum adaptability requirements of modern day manufacturing facilities. Procured through a robust network of suppliers, our wide range of product solutions allows our customers to explore numerous project scope options dependent upon their operational needs. Current clients include: AbbVie, Pfizer, Johnson & Johnson, Roche, GSK, Novartis, Sanofi, AstraZeneca, Abbott, Merck, Eli Lilly, BMS, Allergan, Baxter, TEVA, Mylan, Alexion, Jazz, Napp, Fujifilm

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Richard Keays richard.keays@bcd.ie Tel: +353 (0)63 30200 Railway Road, Charleville, Co. Cork, Ireland www.bcd.com

BCD

For over 30 years, BCD has delivered high purity process systems worldwide to the Pharmaceutical, Biotechnology, Food & Beverage and Chemical industries.

With particular expertise in Product Formulation, Clean in Place, Clean Utilities and Thermal Treatment, our engineers are continually challenged to develop innovative process, mechanical & automation solutions for our clients. These solutions are built and tested in BCD’s skid and vessel workshops comprising of 8,000m2 of assembly space with dedicated testing utilities and facilities.

BCD workshops are dedicated to Stainless Steel and other high alloy materials such as AL6XN, SMO254 and hastelloy. All of its pressure vessels are PED Certified and conform to ASME VIII, PD 5500 or other internationally recognised standards. Our strength is providing highly polished vessels and complex process skids for high purity applications. Backed up by our field installation team who can install these systems and complete field piping and wiring.

Our service and maintenance team provide after sales support that can carry out routine maintenance checks and passivation of these systems.

BCD’s has supplied to the world’s leading pharmaceutical companies including Eli Lilly, Roche, Novartis, Sanofi-Aventis and MSD.

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Paul Boylan paul.boylan@bruceshaw.ie Tel: +353 (0)1 661 4711 Hoban House, Haddington Road, Dublin 4, Ireland www.bruceshaw.com

Bruce Shaw Bruce Shaw is an international construction consultancy firm with over 40 years’ experience, providing Program Management, Project Controls, Project & Cost Management and general consultancy services to the global construction industry. Our experience spans a variety of sectors including Life Sciences.

With offices in 22 locations throughout Ireland, the UK, Europe, the GCC, USA, Asia and Australia, we currently work for clients in 150 cities in over 40 countries around the world including AbbVie, Amgen, AstraZeneca, Genzyme, Jazz Pharmaceuticals and Johnson & Johnson. Our specialist project teams bring a fresh approach to projects enabling us to adapt and be responsive to the evolving needs of our client and the ever changing environment in which we work.

Services provided include: Project Controls

Program Management

Schedule Management

Project Management

Cost Management/Quantity Surveying Contract and Procurement Strategies

Change Management Health and Safety Management

Project Audits

Benchmarking – “Real World Pricing” Arbitration and Costs Settlement

Bank Appraisals Value Engineering and Management

We embrace new technologies and tailor them to the specific needs of our clients, leading to a faster project delivery, greater cost efficiency and maximum value for money. Our consistent delivery of service is reflected in the repeat commissions we are awarded.

4

Donal O’Callaghan donal.ocallaghan@calleng.ie Tel: +353 1 661 4420 Wentworth House, 19-20 Hogan Place, Lower Grand Canal Street, Dublin 2, Ireland www.calleng.ie

Callaghan Engineering Callaghan Engineering, one of Ireland's leading Consulting Engineering firms, offers an alternative professional engineering service integrating the latest technologies with a personal approach. With offices in Dublin and Cork we can meet your requirements for detailed engineering design, project and construction management services, along with validation, procurement, regulatory compliance and consulting expertise in the following sectors:

Biotechnology

Pharmaceutical

Medical Devices

Digital Space

General Industry

Government Agencies

Commercial

Educational

Leisure

Food & Beverages

5

Peter Marron peter.marron@clearsphere.com Tel: +353 (0)21 437 1175 Carrigaline Industrial Estate, Carrigaline, Co. Cork, Ireland www.clearsphere.com

ClearSphere ClearSphere is a single-source provider of Controlled Environment technologies. It has been in business for twenty five years, delivering innovative solutions to blue-chip clients such as Pfizer, Mylan, Abbvie, Stryker, GSK, Jacobs Engineering, PM Group, Roche, MSD and many others. ClearSphere’s success is built on its reputation for technical excellence, quality of service and consistently meeting the highest standards in the industry. It offers a comprehensive portfolio of products and services, covering all aspects of Cleanroom & Containment Operations. In this way a client installation can be designed, installed and validated in a shorter time and at a lower overall cost. ClearSphere’s portfolio is divided into four business units:

Cleanroom Solutions: Design and install cleanroom systems to meet the most exacting standards.

Containment Solutions: Design and install sampling and solvent booths, isolators and lab containment stations.

Validation and Maintenance: Our CTCB-Certified engineers ensure that our customer’s installations meet the required standards.

Product & Equipment: A range of bespoke Clearsphere products and 3rd party items such as filters, isolator gauntlets and lab furniture.

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Michael Browne Division Manager mbrowne@collen.com Tel: +353 1 874 5411 River House, East Wall Road, Dublin 3, Ireland www.collen.com

Collen Construction Collen Construction has been at the forefront of the Irish Construction Industry for more than two centuries. Neil Collen and his wife, the current shareholders, have continued the proud tradition of the Collen family who established the business in 1810. Collen has an excellent reputation for safety, building quality & excellence through people. Our ethos is to provide a quality service and to forge long lasting relationships. Our client list is testament to our positive results. We have a strong focus on our staff and their as they are our most valuable resource and each member is entitled to work in a safe environment. Collen has delivered over €350 million in Highly Serviced Projects in the last 5 years. This specific figure relates to Data Centres and Bio/Pharma projects and equates to over 140,000 sq. metres of Highly Serviced Space. These projects have been completed in Ireland, UK and Germany. Our valued clients include the likes of Ipsen, Amgen, Takeda, Abbott, Intel and others. Collen operates an approved Quality System to NSAI 9001, 14001 and 18001. It is independently audited by NSAI to the current new 2015 standards. Our staff are kept up to date with the fast changing developments in the Life Science sectors through internal knowledge sharing sessions and external training at NIBRT.

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Richard De Zeeuw VP Enterprise Sales rdezeeuw@corasystems.com Tel: +353 (0)71 962 2078 Mercantile Plaza, Bridge Lane, Carrick on Shannon, Co. Leitrim, Ireland www.corasystems.com

Cora Systems Cora Systems provides Enterprise Portfolio, Program and Project Management (E-PMO) solutions and services to large-scale global organisations and government agencies since 1999. Combining our ProjectVision software and experienced Professional Services team enables organisations to deliver real-time, holistic project governance, control and visibility across all projects throughout the entire organisation. The ProjectVision suite of modules are highly configurable for each client’s specific business processes. The system is intuitive and has been designed with a focus on the end-user thereby enabling users to quickly deploy the solution in complex PMO/PPM environments. This in turn helps deliver ROI on implementations in less than 6 months. The system can be configured to deliver dashboards and performance analytics for senior executives, Program Directors, Project Managers, Resource Managers and project team members across the organisation. ProjectVision integrates with leading edge CRM solutions such as Salesforce and ERP solutions such as Oracle and SAP as well as many industry specific third-party solutions, to provide real-time, 360-degree view across the entire organisation from a single, easy to use enterprise platform. Unlocking the available information previously difficult to obtain, empowers organisations to take tactical and strategic control and enable them to institute effective governance and simplified processes.

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Joe Conway joe.conway@dornangroup.com Tel: +353 21 233 0900 10 Eastgate Avenue, Little Island, Cork, Ireland www.dornan.ie

Dornan Engineering Dornan is an International Mechanical, Electrical and Instrumentation services company operating across Europe in a diverse range of construction sectors. At Dornan, we are committed to achieving client satisfaction through safely offering value, deliverability and quality. Over the years we have developed our expertise in the life sciences sector (pharma/biotech) by successfully realising projects for most of the leading multi-national clients such as Pfizer, Abbot, Novartis, Lilly, Johnson & Johnson, MSD, BMS and GSK.

Our services will take any project from the construction drawings right through to final handover and commissioning. We have been providing our Mechanical, Electrical and Instrumentation Services for many years to a diverse range of industry sectors, including Hydrocarbons (Oil & Gas), Life Sciences (pharma/biotech), Energy, Renewables, Data, Manufacturing and the Commercial sector.

From the complex process environment in the pharma/biotech sector to the cutting edge technology and telecommunications required in the commercial market, Dornan has the skills and expertise necessary to efficiently take your project from start to finish.

Today, we employ over 1200 personnel and generate over €200m in turnover on many of the largest capital investment projects currently under construction in Europe.

Our growth is primarily driven by repeat orders from existing clients, demonstrating their level of confidence in our ability to consistently deliver.

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Dan McAlister

+353 (0)1 547 0233

10 Merville Road, Co. Dublin, Ireland

www.eidasolutions.com

EIDA Solutions

Established in 2010, EIDA Solutions brings together a wealth of experience in the construction and technology industries. We have leveraged this domain expertise to develop a ground breaking solution to assist engineering companies in this digital age.

At EIDA solutions, we are dedicated to enabling our clients to reduce project operating costs, enhance quality and optimise site performance, thus differentiating the services that they provide from those offered by their competitors.

We have developed a software product which uses technology to accelerate and simplify the delivery of complex construction projects.

EIDA Solutions’ in-built construction processes, used in a collaborative way by all users’ results in a higher quality of project outputs. This is proven in all our projects to date and our iterative approach to improving these many processes aligns itself with the paradigm of Lean Construction.

One Stop Solution: • Document Management • Quality Assurance • Progress Tracking • Commissioning • BIM Integration • Automated Real-time Reports

Benefits: All users working to a defined process using real-time data which results in improved project productivity, transparency and control.

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Dermot O'Callaghan Commercial Director dermot.ocallaghan@esp.ie Tel: +353 87 832 8905 Nore House, Bessboro Road, Blackrock, Cork, Ireland Tel: +353 21 4614400 www.enterprisesystempartners.com

Enterprise System Partners Enterprise System Partners (ESP) is a leading global consulting and project engineering company – supporting manufacturing IT solutions for the life science industry since 2003.

We offer specialist support and consulting services exclusively for manufacturing and supply chain operations in biotechnology, pharmaceutical and medical devices, with core focus on Manufacturing Execution Systems (MES) and serialisation.

Our specialist consultants and engineers have the expertise to support the concept, planning, vendor selection, design and implementation of the entire manufacturing systems landscape from process automation to the enterprise layer (level 0-4).

We have offices in Cork, Boston, Eindhoven, Istanbul, San Francisco and the Research Triangle allowing us to support projects with local resources worldwide.

Manufacturing Systems

Serialisation, Track & Trace

Laboratory Systems

ERP Systems

Automation Systems

Regulatory Compliance

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Tim Murphy tmurphy@flowtechnology.ie Tel: +353 (0)63 81560 Railway Road, Charleville, Co. Cork, Ireland www.flowtechnology.ie

Flow Technology

We specialise in the design & construction of process installations and the supply of equipment for the biotechnology and pharmaceutical industry. Our key strength is our experienced team of process engineers, design engineers and craftsmen to provide complete competitive solutions for projects.

We have particular expertise in the design, fabrication, installation & qualification of process modules with design & construction based in our own workshops in Co. Cork, Ireland.

Products and Services: Over the past 20 years we have built up an impressive track record in the Pharmaceutical Industry with a wide range and frequency of repeat business indicating a high level of customer satisfaction with our work

We have experience of the design, fabrication, installation & qualification of:

Chromatography

Depth, Ultra & Nano Filtration

HTST systems

Cleaning In Place

Temperature control skids

BioWaste Deactivation

Purified water distribution

Purified water point of use

Transfer panels

Key Clients: • Pfizer • Johnson & Johnson • Eli Lilly • Pepsi • Irish Distillers • AbbVie • Baxter • MSD • Allergan • Sanofi • Lonza • Kerry Ingredients

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Michael Darcy CEO michael.darcy@hal-software.com

Tel: +353 (0)1 280 4839 Ashgrove House, Kill Avenue, Dun Laoghaire, Co. Dublin, Ireland www.hal-software.com

Hal Software Founded in 2012, Hal Software is a provider of Industrial Control and MED prototyping software. Prototyping is used to significantly reduce time, risk and cost on Industrial Control and MES projects.

Other benefits of using prototyping include:

More accurate project cost estimation

Increased cross functional collaboration

Training

Knowledge Management

Operational Excellence

The software, Spike Prototype™, is designed for use by process, automation and MES engineers within EPCs, systems integrators and end users.

Features include:

Drag and drop for ease of use

Macro recorder and video capture for lightning fast record and playback of functionality

Web server to enhance collaboration

Control system independent

High level programming language (python)

Integrated workflow engine

Caters for any level of fidelity and ability, allowing individuals with no control system

20+ reports that can be generated automatically, including functional requirement specifications and test protocols

Code snippets, help functions and auto-complete to make programming as simple and rapid as possible

Standards based, with inbuilt ISA-S88 and ISA-S95 design pattern type libraries, and documentation in accordance with ISA 5.06

OPC-UA at the core to enhance interoperability, object oriented data modelling, Industry 4.0 training and testing

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Paul Hanley paul@hanleyenergy.com Tel: +353 (0) 1 8414832 Unit 7-8, Block 4, City North Business Park, Stamullen, Co. Meath, Ireland www.hanleyenergy.com

Hanley Energy Hanley Energy is a globally recognised, award winning innovator headquartered in Ireland and with offices in the US, Germany and the Nordics. Equipped with a wealth of experience and expertise spanning 80 years, we specialise in the design, source, supply, install and commission of critical power and energy efficient solutions from the power grid all the way to the factory process equipment and Data Centre IT rack, coupled with comprehensive service and maintenance, consulting and training. In this way, we help our clients to reduce energy costs, ensure 100% up-time and optimize operational competitiveness. Solutions provided include:

Infrastructure Procurement and Solutions such as Transformers, PDU, Racks, Cooling and UPS

Turnkey Modular Data Centres ranging from 1MW to 5MW

Micro Data Centre Infrastructure for remote and branch office.

Full Power Management and Automation Control Solutions

Powerlink+ Utilities Monitoring Software & DCIM

Transactional sales of power related products

Service & Maintenance

Certified Critical Power and Power Management Training

Our approach is to develop partnerships with clients, ensuring excellent delivery coupled with cost-effective technology solutions.

14

Mark McLean Chief Technical Officer mark.mclean@teamhorizon.ie Tel: +353 (0)98 50600 One Cedar Crescent, Cedar Park, Westport, Co. Mayo, Ireland www.teamhorizon.ie

Horizon Horizon Life Sciences Group (“Horizon”) is a solutions provider to the life sciences sector globally. The Group’s subsidiaries include Team Horizon, who provide expert engineering services and project management to the life sciences industries, and SeriCode, the strategic partner for serialisation implementation in the pharmaceutical industry. Founded in Ireland in 2010, by Aiden Corcoran and Mark McLean, the group’s headquarters are based in Westport, County Mayo, with offices in Dublin, Ireland and Philadelphia, USA. Its client base includes 15 of the top 30 global medical device firms, 16 of the top 30 global pharmaceutical firms and 5 of the top 10 global biotechnology firms. Since its establishment the company has expanded ten-fold, and has successfully built a reputation as a solutions provider with in-depth knowledge of manufacturing engineering within the life sciences sector. With a team of dedicated experts, Horizon’s client base now includes life sciences companies in Ireland, Europe and across North America. Awards such as Ireland’s SFA’s Service Business of the Year 2015, Ulster Bank Business Achievers Award 2015 and the SFA’s Emerging Business of the Year Award 2013 highlight the success of the business. Horizon are ISO 9001 accredited. Horizon are dedicated to developing products and solutions to aid the health, safety and well-being of the global community, through its clients.

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Liam Casey Business Development Director lcasey@johnpaul.ie Tel: +353 (0) 87 222 2350 Dundrum Business Park, Dundrum Road, Dublin 14, Ireland www.johnpaul.ie

John Paul Construction

John Paul Construction are leading international specialists in construction, infrastructure and fit-out. Founded in 1949, the company is a market leader with a portfolio of major Pharmaceutical projects for Global Clients.

John Paul Construction provides a comprehensive range of construction services to our clients, such as management contracting, design and build, partnerships/turnkey arrangements as well as traditional contracting. With offices in Dublin, Cork, London and Riyadh we have the scale and resources to deliver large and complex Pharmaceutical projects.

We are renowned for achieving excellence in quality, innovation and delivery while providing our clients with a level of service that exceeds their expectations. This is reflected in the level of repeat business and the long term relationships we maintain with our client base. As a value driven company, we are passionate about delivering enhanced value at all stages in the construction process and working collaboratively with all project stakeholders.

John Paul Construction has a proven track record of providing the right team with the skills, knowledge and experience to consistently deliver above and beyond expectations.

Current clients include: Alcon Laboratories | Alkermes | Alltech Bioscience | Bausch and Lomb | GSK | Helsinn | Merck Millipore | Merck Sharp & Dohme | Sysco

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Paudie O’Se Regional Manager p.o'se@sisk.ie Tel: +353 86 809 1210

Wilton Works, Clondalkin, Dublin 22, Ireland www.sisk.ie

John Sisk & Son Ltd

John Sisk & Son, member of the SISK Group, is an international construction company, who place a strong emphasis on Safety Performance, Quality, Teamwork and a hands-on management approach to ensure client satisfaction. Family ownership for five generations has set the cultural tone for John Sisk & Son. We have been Building Excellence for over 150 years by building trust, certainty and value for our clients.

John Sisk & Son can be relied upon to keep delivering. We take a long term view of business, investment and relationships. Our knowledge and skills are augmented by the financial strength and expertise of the SISK Group. Our overriding focus is on delivering performance in the safest possible manner. We take our quality, safety and environmental sustainability responsibilities extremely seriously and pride ourselves on our standards and records. Achieving Zero Incidents & Zero Accidents continues to remain our top priority for our staff, clients and projects, laid out in our Zero philosophy.

We have delivered over well over a Billion in the Pharmaceutical Industry and have transferred this expertise and successful delivery to Europe. Relationships have been the key to our past can do attitude combined with a Teamwork philosophy lies at the heart of our culture. We work together with our customers, professional teams and our supply chain to develop innovative and value adding solutions for our clients. Protecting the welfare of future generations is also reflected in our approach to sustainability and bringing environmental, social and economic benefits to our clients and the wider community.

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Barry Steele Business Development Manager bsteele@joneseng.com Tel: +353 (0)1 671 1500

Waterways House, Grand Canal Quay, Dublin 2, Ireland www.joneseng.com

Jones Engineering Group

Jones Engineering Group is the leading Engineering Contractor in Ireland. The Group currently employs approx. 2,400 people, with a turnover in excess of €400m per annum. Over 80% of this is with existing clients, testament to our delivery of work safely, on time, within budget and to the highest standard of quality.

We have been servicing some of the world’s largest pharmaceutical companies for more than 40 years. We have a real understanding of the particular protocols, procedures and client expectations that are required to deliver a first-class service in this demanding environment.

The group offers the complete range of engineering services including: Mechanical / Electrical / Fire Protection / Process Pipework / HVAC / Instrumentation / Calibration / Commissioning / Maintenance / Heavy Lift Specialist / Waste to Energy / Geo Surveying / Compex Training

Our capabilities range from Project Management, Budget Estimates, Scheduling, Engineering, coordination, Procurement, Value Engineering, Construction Management, Training, Design-Build, Term Service Contracts, Turnarounds & Shutdowns, Operation & Maintenance, Inspection, Commissioning & Plant start-up and Turnkey Construction. We have a number of highly skilled multi-disciplined project management and construction teams. These teams have skill sets tailored to suit the particular requirements, protocol and procedures of the wide range of clients we serve across the Pharmaceutical, Electronic & Data Centre, Medical, Heavy Industry, Food & Beverage and Commercial sectors.

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Michael Hennessy Associate Director mhennessy@kirbygroup.com Tel: +353 (0)1 454 0411 White Swan Business Park, South Circular Road, Dublin, Ireland www.kirbygroup.com

Kirby Group Engineering Our clients come first, making Kirby the most trusted provider of high-value engineering and installation solutions across all our sectors. Kirby is a multi-disciplinary engineering services contractor to the life science sector in Ireland, the UK and Continental Europe. The group is privately owned and employs in excess of 600 personnel working from 7 offices with a turnover of €150m. We provide Mechanical Piping, Electrical, Controls / Instrumentation and HVAC services to end user clients and their project partners in biologics, secondary and primary API facilities. We also have an extensive client base and project portfolio within the med-tech, diagnostics and nutritionals sectors. Innovation and proactive engagement on projects is the cornerstone of our success in the sector. We are strong advocates of LEAN based construction techniques such as off-site fabrication, integrated modelling, life cycle costing and have developed our own in-house expertise in these areas particularly around BIM modelling, integrated project deliver (IPD) and engineering development. We work with leading organisations in the sector such as Sanofi Biologics France, GSK, BMS, Roche, Abbvie and Regeneron on complex new build and upgrade projects delivered to exacting standards and within tight project timelines. Kirby is accredited across all Q-EHS standards including ISO9001, OHSAS18001 and EN14001. The company consistently receives recognition from representative industry bodies and our clients for our high performance against Q-EHS requirements on projects.

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Eddie Ryan CEO eddie.ryan@kneat.com Tel: +353 (0)61 203826 Unit 7 Castletroy Business Park, Castletroy, Limerick, Ireland www.kneat.com

Kneat Solutions

Kneat’s enterprise software application, Kneat Gx delivers an unprecedented capability for Pharmaceutical, Biotech and Medical Device companies to become paperless, compliant and efficient with many of their regulated data and document intensive processes. Kneat Gx was built for Life Sciences and so meets the stringent applicable regulatory requirements such as all cGMPs, Part 11, Annex 11 etc.

The Kneat platform can be used to completely tailor a solution to implement many business processes such as:

All Validations - Equipment, Computer, Cleaning, Laboratory, Method, Process, etc.

Periodic Review and Re-Validation Management

Equipment Changeover Management

Risk Lifecycle Management (Risk Assessments)

Automation Lifecycle Management

Change Control, CAPA, Deviation Management etc.

Commissioning and Qualification

Project and Construction Management

And much more

20

John Devlin CEO john.devlin@kpc-international.com Tel: +353 (0)21 2307087 NSC Campus, Mahon, Cork City, Ireland www.kpc-international.com

KPC International

KPC International is a key supplier of specialist project related services to the Pharmaceutical and Bio-pharmaceutical industries. Services range from Project / Program Management to Commissioning & Qualification, Operational Readiness and Business Continuity.

Specific areas of expertise include:

Project / Program Management

Turnkey Capital Project Execution

All aspects of Commissioning and Qualification from strategy development to test execution.

Operational Readiness including assisting the Operation Organisation in the planning and execution of readiness activities such as SOP writing, Batch Record, Change Control.

Post OQ Activities such as PQ, cleaning Validation, Shipping Validation.

Quality, Compliance Consulting and Auditing

KPC International personnel have gained their expertise by integrating with client teams on a number of large scale projects in Europe and USA. KPC International has the capability to support projects on site in most countries and have a track record of supporting projects in remote locations around the world.

KPC International has offices in Ireland, Switzerland and Singapore with further offices planned in Eastern Europe and China.

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Kieran Coughlan Managing Director kcoughlan@lsc.ie Tel: +353 (0)21 477 7329

Kinsale Commercial Park, Kinsale, Co. Cork, Ireland www.lsc.ie

Life Science Consultants

Life Science Consultants (LSC) is a specialist resourcing company focused on providing resourcing, recruitment and consultancy services for the Pharmaceutical, Biotechnology & Medical Device industries.

LSC is committed to providing a service based around industry knowledge. An in-depth knowledge of the current market & industry trends allows us to provide a bespoke service to our clients in the pharmaceutical, biotechnology & medical device sectors.

Our mission is to work closely with our candidates and clients, guiding technically qualified and experienced engineers and scientists through the recruitment process, matching the best people with the best roles.

LSC is focused on sourcing skilled professionals for Manufacturing, Engineering, Quality, Tech Services and Supply Chain roles.

Our clients rely on our expertise in these areas to provide the best available talent. We view our client and candidate relationships as partnerships. These partnerships are maintained on the basis of openness, communication and understanding, where our technical industry experience & market knowledge allows us to work with candidates from graduate level right the way through their careers.

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Ronan O’Kane Group Head of Sales ronan.okane@mercuryeng.com Tel: +353 1 216 3000 Mercury House, Ravens Rock Road, Sandyford Ind. Estate, Dublin 18, Ireland www.mercuryeng.com

Mercury Engineering Mercury are Ireland’s largest Engineering Contractor and an internationally recognised provider of complex engineering and construction services. Since the company’s formation in 1972, the company has built on relationships and grown organically to be the leading Contractor in our home market and a major competitor across Europe. We specialise in HVAC, Process, Electrical, Instrumentation & Commissioning, Data & Telecoms and Fire Protection Installations. The company also in an industry leader in LEAN, BIM and Off-site construction. Facts and Figures:

Over 43 Years in business

Privately owned

Worked in 27 countries on 4 continents

Over 2,000 direct employees and 1,500 sub-contractors across Europe

Established international and local supply chains

Annual revenues exceeding €500m ($700m+)

Best in class BIM capabilities

Extensive network of off-site fabrication specialists

High levels of repeat business with existing clients

Mercury have a proven international track record. Projects are supported from our headquarters in Dublin and our regional bases in the UK, Holland, Warsaw and Russia. We have a strategy of engaging a local supply chain wherever we operate which ensures excellent project support and long term sustainability. Please visit our website for further information.

23

Dave Ronan Business Development dave.ronan@mslengineering.ie

Tel: +353 (0) 21 4513550 Unit 8 Watergrasshill Business Park, Watergrasshill, Co. Cork, Ireland www.mslengineering.ie

MSL Engineering Ltd. MSL Engineering Ltd. is a mechanical engineering contractor dedicated to delivering a service that incorporates the highest standards of workmanship, safety, quality and reliability. MSL Engineering Ltd. has a record of over 35 years of excellence in mechanical engineering. We deliver mission critical projects to some of the world’s leading companies, including Pfizer, GlaxoSmithKline, Eli Lilly, Alexion, Mallinckrodt, Bristol-Myers Squibb, Stryker, Glanbia, Pernod Ricard, Phillips66, BGE, ESB and GE. Currently operating across Ireland, UK, Belgium and The Netherlands, MSL Engineering Ltd. specialize in

Fabrication, installation, testing and commissioning of process, utilities, and high purity pipework

Modular fabrication and assemblies

Process and heavy equipment installation

Fabrication and installation of platforms and steelwork

Managing multi-discipline sub-contractors as part of our projects including HVAC, scaffold, craneage, insulation, painting, NDT etc.

Use of BIM and 3D modelling processes MSL’s business encompasses one-off construction contracts in addition to ongoing maintenance and term service contracts across many industry sectors such as

Biopharma

Pharmaceutical

Medical Devices

Chemical

Power & Utilities

Data Centres

Food & Beverage

Oil & Gas

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Killian O’Driscoll killian.odriscoll@nibrt.ie Tel: +353 (0)1 215 8100 Foster Avenue, Mount Merrion, Co. Dublin, Ireland www.nibrt.ie

NIBRT

The National Institute for Bioprocessing Research and Training (NIBRT):

Provides training and education to produce highly skilled personnel for the biopharma industry.

Conducts world-class research and innovation in key industrial areas of biopharma.

Provides flexible, multipurpose biopharma research and training facilities.

The NIBRT facility (6,500m2) provides a range of opportunities for industry including:

Showcase of new products and latest technology.

State-of-the-art training and pilot plant facilities.

Beta test facility of new engineering and manufacturing concepts.

Scale-up facility for research and innovation collaborations.

NIBRT has a diverse client portfolio including biopharma manufacturers, regulatory agencies and vendors.

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Angela Drum Business Development Manager angela.drum@oeesystems.com

Tel: +353 (0)52 617 0386

Gurtnafleur Business Park, Clonmel, Co. Tipperary, Ireland www.oeesystems.com

OEEsystems International OEEsystems International provide OEE Manufacturing Performance Management software solutions to the world’s most progressive manufacturing companies. We work with companies like Allergan, GE Healthcare and CooperVision helping them to improve productivity and competitiveness, adding millions to the bottom line. Our OEE software solution PerformOEE™ automates the collection and analysis of manufacturing data in real-time, providing you with complete visibility into your manufacturing processes and a continuous stream of production losses to focus on and fix. Why OEEsystems International?

We are OEE Specialists who focus solely on delivering “World Class” OEE Software and Expertise.

We are OEE Innovators for example we have adapted the OEE model and our OEE Software to handle Batch API processes as well as continuous and discrete manufacturing.

We are Manufacturing Experts who take an Operational Excellence (OPEX) approach to OEE rather than a Top Line or Technical approach.

We are experts in delivering OEE Software projects worldwide with installations in Europe, the US and Asia.

We are known as the company that make OEE improvements actually happen.

Our proven Return on Investment is rapid and the software will typically pay for itself within 6 months or less.

Next Step To request a PerformOEE Software Demonstration or for more information on our 30 Day Software Trial contact Angela Drum, Business Development Manager.

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Brian Mulhare b.mulhare@panelduct.ie Tel: +353 86 041 0601 Moneen Road, Castlebar, Co. Mayo, Ireland www.panelduct.eu

PanelDuct® Ireland

PanelDuct® is the Irish Times 2015 InterTradeIreland Innovation products awards winner. PanelDuct® is a flat-pack pre-insulated ducting system which has been successfully installed by the Tesco Group, Dunnes Stores, Medtronic & Ashford Castle together with DigiPlex in Sweden. PanelDuct® has been awarded patents throughout Europe, USA & Asia.

Key drivers for the Construction Team:

Speed of installation – single fix with no follow on required for insulation and cladding.

Less trades – no lagers or cladders needed on the site.

Product supplied in flat-pack format - single crane lift onto the roof.

Site storage requirement – reduced by up to 80% when compared to traditional systems.

Ideal for MEP off-site assembly into packaged risers, corridors and/or plant-room modules.

Certainty of building program as PanelDuct® can easily be adjusted with basic tooling on site should unforeseen obstructions arise.

Aesthetically pleasing finish with Architects choice of RAL colours.

End User lifetime advantages:

Air tightness in excess of Class D as certified by BSRIA.

Reduced heat losses/gains due to excellent thermal characteristics.

Reduction in carbon footprint due to significantly less energy losses.

Acoustic benefits from composite panel design as certified by NoiseAir & SRL.

Excellent fire rating to Euroclass Bs3d0 as certified by Exova WarringtonFire.

Extremely robust (outer steel casing can be walked on without causing any damage).

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Sean Carrigy sean.carrigy@pjhegarty.ie Tel: + 353 (1) 455 6270 Davitt Road, Inchicore, Dublin 12, Ireland www.pjhegarty.ie

P.J. Hegarty & Sons

Established in 1925, P.J. Hegarty & Sons are a leading building and civil engineering company undertaking projects throughout Ireland and the UK from offices in Dublin, Cork, Limerick and London. With over 90 years in business, PJ Hegarty has built up significant resources and expertise, with 225 people directly employed. Our primary activity is undertaking large, complex projects in infrastructure, commercial, pharmaceutical (including working in live pharmaceutical facilities), retail, tourism, and institutional buildings, refurbishment and civil engineering works. PJ Hegarty offers a full range of construction services including management contracting, design & build, alliance/partnering and PPP contracts, in addition to traditional building arrangements. The range of work undertaken varies in type and size from multimillion euro/pound contracts to small and medium sized projects. Safety is our company’s core value and we operate a safety management system which is accredited to both Safe-T-Cert and CHAS. PJ Hegarty is fully committed to providing a quality service – completing projects to the highest standards, on time and within budget. The Company is certified to ISO 9001:2008 and to ISO 14001: 2004 standards. Our Client base includes

GSK GlaxoSmithKline

Pfizer Pharmaceuticals

Merck Sharpe & Dohme

Bristol Myers Squibb.

Eli Lilly

Wyeth

Janssen

Boston Scientific

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Seamus Kelly seamus.kelly@pmgroup-global.com Tel: +353 21 435 8922 Loughmahon Technology Park, Blackrock, Cork, Ireland www.pmgroup-global.ie

PM Group PM Group is an international project delivery company operating across Europe, the USA and Asia. We have a 40 year track record in project management, process design, facility design and construction management for leading multinational companies. We are world leaders in the pharmaceutical, food, mission critical, medtech, advanced manufacturing and energy sectors. Our reputation is built on great people with a flexible ‘can do’ attitude who consistently deliver successful projects safely for our clients. Our team of specialists has successfully delivered pharma and biotech projects of all types and sizes for the biggest names in the business. We are the Number 2 ranked international pharma design firm* thanks to our world-class skills and ability to partner with our clients (*ENR Global Sourcebook)

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Paul Dempsey Senior Electrical Projects Engineer pdempsey@premium-power.com Tel: +353 (0)1 8105032 2A Fingal Bay Business Park, Balbriggan, Co. Dublin, Ireland www.premiumpower.ie

Premium Power Premium Power is an electrical engineering consultancy providing safe, reliable, and cost effective solutions for the pharmaceutical and manufacturing industry and utility and renewable sectors. Premium Power design and deliver specialist electrical systems, using system studies, power quality and reliability mitigation solutions. They specialise in delivering: Electrical Resilience Premium Power can reduce the risk of unplanned outages and ensure maximum uptime by designing and troubleshooting electrical systems, assessing single point of failure, power quality studies, solution design and delivery. Electrical Safety As well as training operators and engineers on electrical safety, Premium Power measure and mitigate the risk of electrical arcing and develop electrical safety procedures and risk assessments that are industry specific. Electrical Design Premium Power provide energy efficient design and project management of electrical upgrade works. They are specialists in embedded generation, designing systems for sub-stations, large scale renewable projects, airports and data centres. Premium Power’s unique selling point is in integrating technologies required to deliver reliability and cost effective solutions for averting catastrophic and mission critical power system failures. They deliver substantial long term cost savings for leading pharmaceutical, data centres and utilities, where power system failure can cost millions of euro in direct and consequential losses. Premium Power Services: • Electrical Reliability Studies • Maintenance planning • Power Quality Analysis • Power Quality & Harmonic Mitigation Design • Energy and Power Quality Metering Systems • Arc Flash & Electrical Safety Studies • Electrical Safety Training

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Donal Higgins donal_higgins@prochem.ie

Tel: +353 (0)56 7790100 14 Danville Business Park, Kilkenny, Ireland www.prochem.ie

Prochem Engineering

Prochem Engineering is an engineering consultancy firm specialising in design, project & construction management and consultancy contract services.

Prochem is active in the pharmaceutical, bio-tech, medical device, and industrial and health sectors with a multi-disciplinary team of over 80 people working in 20 different plants throughout Ireland. We have carried out many large and small scale projects for multinational pharmaceutical clients and has become a market leader with a long experience of working within FDA & EU environments. We understand the needs of our clients and this is reflected by the services that we offer.

Prochem’s services include:

Conceptual and Front End Studies

Process Engineering Design

Project Engineering

Electrical Design

Health & Safety

Instrument & Control

Commissioning, Validation & Qualification

Project Management

Construction Management

Current clients include BMS, Pfizer, MSD, Genzyme, TEVA, Clearstream, Leo Labs, Glanbia, Amneal, West, and J&J.

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David Monaghan Commercial Director david.monaghan@prostainless.ie Tel: +353 (0)41 6859967 Pro Stainless Designs Ltd., Ardee Business Park, Ardee, Co. Louth, Ireland www.prostainlessdesigns.com

PRO Stainless Designs ENGINEERED FOR DEMANDING REQUIREMENTS At PRO Stainless, we have brought together the expertise, the team, the craftsmanship and the facilities to deliver the most challenging of stainless steel projects. Since 2001, we have been developing innovative high-end solutions for cleanrooms & hygienic environments, architectural metalwork purposes and production & manufacturing sites across Ireland, the UK and internationally. CLEANROOMS & HYGIENIC ENVIRONMENTS Cleanrooms, hospitals, laboratories and food processing areas demand increasingly high hygienic standards to avoid contamination and reduce commercial risk. PRO Stainless produce high-end solutions with ultra-smooth polished finishes, eliminating particles collection, ensuring super-clean surfaces. 3D modelling, electro polishing and bead blasting services are available on all projects. STAIRS & PLATFORMS All our platforms and stairs are CE marked in accordance with EN1090 Standards. They are structurally designed and constructed in accordance with building regulations and applicable EN codes.

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Michael McLoughlin info@prosys.ie Tel: +353 (0)21 485 3900 IDA Business Park, Carrigtohill, Co. Cork, Ireland www.prosys.ie

ProSys Containment & Sampling Technology

ProSys designs and manufactures Isolators (Gloveboxes) and Sampling Systems for the Pharmaceutical Production Industry. Our products contain the hazard in a closed system and maintain an environment that is safe for all personnel.

International Containment Expert Team

Automation Expertise including PLC, HMI, SCADA, Batch, GAMP, 21 CFR Part II.

Mechanical Design & In-House Fabrication

State of the art Manufacturing Facility with ISO 7 (Class C) Cleanroom for Containment Testing

Expedited Project Delivery To discuss a project or any containment or sampling applications, please feel free to contact us.

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Paul O’Riordan paul.oriordan@radleyeng.ie Tel: + 353 87 313 5915 Killadangan, Dungarvan, Co. Waterford, Ireland www.radleyeng.ie

Radley Engineering Ltd With a turnover of €30 million, currently employing 300 people, Radley Engineering Ltd., is one of Europe's leading specialists in the design, manufacture, fabrication and site installation of high quality stainless steel, carbon steel and other exotic materials (304L, 316L, 904L, Hastelloy C22/C-276, Duplex, Incoloy, etc.).

Site Facility includes: Carbon Steel Pipework Fabrication workshop

(3,500m2)

Segregated Stainless Steel Pipework Fabrication Compound (2,500m2)

High Purity Pipework Facility (2,000m2). Clean-room to Class 10/1000/10,000 for the semiconductor/bio pharma industry (Intel)

Mechanical Site installation division. Clients include; M.S.D., Amgen, Regeneron, Pfizer’s, Sanofi/Genzyme, Eli Lilly, Glanbia etc.

Architectural Division

Products include: Vessels (Pressure & Atmospheric)

Modular Design Skids & Structures (Clients include: GSK, Phillips, Intel)

Storage/Heating/Cooling Tanks

Heat Exchangers & Condensers

Reactors & Process Columns

Sub Sea Drilling Risers (Clients include: Cameron, Statoil, Total, BP)

Radley Engineering Purpose built facility is also capable of:

Welding (Orbital, Automatic & Manual Process)

Machining & Polishing

De-Greasing & Cleaning

Passivation & Heat Treatment

Shot Blasting & Painting.

The success of Radley Engineering Ltd., has been driven by a set of core values of Safety, Integrity, Environment, Teamwork, Respect and Performance, all the while maintaining the highest standards in Quality.

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Barry Hennessy Business Development Director bhennessy@winthrop.ie Tel: + 353 86 775 4700 Unit 7 Turnpike Business Park, Ballymount, Dublin 22, Ireland www.winthrop.ie

Winthrop Engineering and Contracting Ltd Winthrop are one of Ireland’s leading Mechanical, Electrical & Instrumentation Engineering companies with a current turnover of €77m, and projected turnover in excess of €100m in 2016. Established in 1995, Winthrop directly employ over 600 people. Our focus is on the safe delivery of quality projects, on time and within budget. Large complex projects have been delivered across the Commercial, Data Centre, Industrial, Healthcare, Pharmaceutical and Public Works sectors. The full scope of mechanical, electrical and instrumentation services are offered, including engineering, project management, design, build, & construction Winthrop has delivered demanding projects across all sectors of business and industry. We frequently operate in difficult conditions such as in live environments, handling critical services, and also to tight time deadlines. Winthrop has delivered, and continues to deliver, large complex projects across the Bio-Pharma Sector for Global brands such as: Alkermes, Genzyme, Bausch and Lomb, MSD, Regeneron, GSK, TEVA, Maya, and more. With total Biopharma project delivery value’s now exceeding €60m over the last two decades. Winthrop are EQA certified for OHAS-18001, ISO-9001, ISO-14001 and a Safe-T-Cert A rated company. Winthrop's IMS system is Certified by external auditors EQA and the IMS is designed to deliver all our Projects with an efficient and consistent approach, and specifies the BCAR requirements for all projects.

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