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Volume 66: Issue 6 I November/December 2012 www.engineersjournal.ie ISSN 0332-1711 www.engineersjournal.ie Janssen Ireland Engineers Ireland CPD Company of the Year 2012
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Page 1: Janssen Ireland - Engineers Ireland

Volume 66: Issue 6 I November/December 2012 www.engineersjournal.ie

ISSN

033

2-17

11

www.engineersjournal.ie

Janssen IrelandEngineers Ireland CPD Company of the Year 2012

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272 Volume 66: Issue 6 I November/December 2012 www.engineersjournal.ie

Within Ireland, Johnson & Johnson (J&J) has a very strong presence with over 1,800 people employed by companies that comprise Jans-sen Biologics, Janssen Pharmaceutical, Janssen AI, DePuy-Synthes, Vistakon, Johnson & Johnson Medical and Consumer, Janssen Cilag and Janssen R&D. Although these organisations span diverse sectors such as medical devices, pharmaceuticals and biologics, they come together to form J&J Campus Ireland, an entity that leverages the combined strength of these companies and promotes best practice and knowledge-sharing. Commercial benefits are gained through common procurement and service provider contracts in the areas of energy, utilities and facility services. The sharing of best practice is generating tangible value by allowing common functional groups to share their experience and skills for the benefit of the entire campus, according to Janssen Ireland.

Janssen Ireland is part of the J&J group of companies and comprises two pharmaceutical manufacturing facilities located in Little Island and Ringaskiddy, in Cork.

New era in pharmaThe Janssen Pharmaceutical Active Pharmaceutical Ingredient (API) site is manufacturing at the Little Island facility for 32 years. With a reduction in new molecular entities, product patent expiry, generic manufacturing competition and increasing costs, the facility focused on reconfiguring its operating model by driving cost improvement in support of supply reliability to influence its manufacturing network and to direct incremental volumes to the Cork API facility.On a greenfield site in Ringaskiddy, the Janssen Biologics facility commenced construction in 2005, aiming towards manufacture of

Chain reaction Janssen transforms Cork facilities for new era in pharmaThe Janssen Ireland CPD team reports on how the CPD Company of the Year, in a changing operating environment, transformed its pharmaceutical facilities, leveraging a sustained programme of CPD processes to successfully implement visionary business models delivering new benchmarks in productivity and competitiveness while securing staff retention and creating additional jobs

Janssen Biologics Facility, Ringaskiddy

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two biologics products. Both sites were challenged with attracting new business to sustain their viability. To succeed, both sites required a strategic operating model that took account of local and global considerations. Both are part of the global J&J organisation. However, with international sites being strategically designed to act as backup sites to each other for business continuity, it was critically important for both Cork sites to ensure they positioned themselves to be part of, and contribute to, the long-term J&J strategic plans. Therefore, the issues facing the two sites were local Irish issues and required an Irish-led effort to gain business within the J&J world to ensure Irish job retention. On that basis, the business models for both sites were re-designed with a view to capitalising on these sites’ reputation within J&J for having a talented workforce with a can-do attitude and for project delivery on time and within budget. A key factor in re-designing the business models was the development of a CPD policy whose mission statement was to ‘attract, motivate and retain’ employees. The Janssen Ireland leadership team developed strategic plans posi-tioning both Cork sites to enable them to deal with the challenges.

The Janssen Biologics strategyThe Ringaskiddy site positioned itself to influence the J&J organisation to bring clinical manufacturing capabilities on the back of its success-ful delivery of the main commercial facility on time and on budget with a successful regulatory licence awarding on first application and a local culture of continuous improvement within its organisation. This was achieved by implementing the following initiatives:

utilisation of the unused manufacturing capability of Janssen XX

Ireland to commence manufacture of new development/toxico-logical and clinical phase (Phase 1 – 3) drugs;re-engineering of the site facility to be capable of multi product XX

production;organising two new small-scale toxicology/development/clini-XX

cal upstream and downstream suites (within the confines of the existing manufacturing floor space) to produce early phase

material;maximising use of new technologies to minimise costs and cycle XX

times e.g. disposable technologies;moving early stage production (development/toxicological and XX

clinical phase) to Janssen Biologics resulting in minimising the risk and cost associated with the technology transfer step at a later stage; and,relocating of process development and material sciences XX

(PDMS) analytical laboratory to Cork to support product tech transfers.

The Janssen Pharmaceutical strategyThe Little Island site positioned itself to influence the J&J organi-sation by bringing reliable capacity and implementing continuous improvement to ensure allocation of potential incremental forecasted volumes of products to this facility providing the necessary associ-ated cost absorption within the existing footprint and headcount. This was achieved by:

increasing the capacity occupancy for sterile API’s from 30 per XX

cent to 90 per cent thus consolidating the facility as the primary manufacturer of sterile API within the global network; and,achieving regulatory approval for campaign manufactur-XX

ing of sterile API to ensure shorter manufacturing cycle time and fully utilised equipment occupancy result-ing also in a >10 per cent yield increase per batch.

Key CPD (Continuing People Development) processesThe Janssen Ireland CPD mission Statement is ‘attract, motivate and retain’. From this, the Janssen Ireland CPD Policy was derived, a summary of which is: “In addition to formal training, it is Jans-sen Ireland’s policy to encourage all employees to participate in all aspects of the organisation’s development activities both internally and externally.” Therefore, when undergoing new and challenging projects such as the new clinical suites and sterile API manufacturing, it was the aim of the company to utilise the employees in key roles. Another

www.engineersjournal.ie Volume 66: Issue 6 I November/December 2012 273

Pictured at the presentation of the CPD Company of the Year Award to Janssen Ireland (l-r): Alan Bateman, Janssen Ireland; Tom Nyhan, Janssen Ireland; John Power Chartered Engineer, Director General, Engineers Ireland; Dr Michael Napier, Global Technical Services Janssen Ireland (with parchment) and John Kelly, Janssen Ireland.

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Engagement Communication

Collaboration Employee Involvement

BusinessStrategy

Human ResourcesStrategy

Organisational Culture

Employee Business

Satisfaction &Engagement

Performance & Results

Compensation& Benefits

Performance & Recognition

PersonalDevelopment& Career opportunity

+

ATTRACTMOTIVATE

RETAIN

274 Volume 66: Issue 6 I November/December 2012 www.engineersjournal.ie

relevant extract from the CPD policy states: “The company also benefits from employees’ CPD as it leads to the achievement of world class standards in, for example, quality, environmental, health and safety (EHS) management, maintenance and engineering excel-lence and business excellence.” The immense success of these projects can be attributed to the involvement of the employees in their design, implementation and support. The focus on using internal employees in leading project roles resulted in innovative solutions which put the Cork sites ahead of competitors in new technologies and in the provision of cost-effective and targeted world-class in-house solutions which intimately suited the existing culture, architecture and design of the two sites.J&J fosters a 70/20/10 approach to people development –70 per cent on-the-job, 20 per cent feedback and coaching, and 10 per cent other activities including training. Therefore, by utilising its exist-

ing talented workforce to work on these projects, allowed Janssen Ireland to have a considerable

advantage by having an on-tap range of the required project resources available with no time wasted in train-

ing up new resources. To keep abreast of fast-churning technology, the company has continuously kept its people

up up-skilled with new technologies by supporting employees to attend seminars, conferences, workshops, training courses,

cross-sector/site knowledge-sharing opportunities etc.

a)Formal CPDIn addition to having a defined training curriculum by job func-tion using the sites training programme, a number of custom-made courses have been developed by Janssen in conjunction with educa-tional bodies. These courses can be used as credits towards further education:

a tailor-made course was designed and delivered in XX

Members of the Janssen CPD Team.

70%on the job

20%feedback & coaching

10%other activities

Cornerstones of the CPD process.

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collaboration with IT Tallaght to effectively train employ-ees in sterile manufacturing/aseptic techniques;a customised automation course was developed by Jans-XX

sen in association with Cork Institute of Technology (CIT)aimed at broadening the automation knowledge of opera-tions, quality and support service departments in order to deliver right first time, sustainable manufacturing and,Dynochem-user training was organised by Janssen to train XX

key process experts and engineers on using the Dyno-chem software package to deliver a structured approach to problem-solving process schemes, equipment characterisa-tion, process assessment and crystallisation process design.

b)Knowledge sharing activitiesJanssen Ireland has employed a number of knowledge sharing activi-ties including:

a formal mentoring process (as part of the company’s XX

business objectives, initiated and driven from the CPD committee, a mentoring programme is now active);accelerated learning unit (ALU) – ALUs are used to optimise XX

business processes so that the sites can be run efficiently and the benefits sustained – an ALU is made up of a cross-func-tional team where people get the opportunity to design and implement improved and more efficient site processes; and,

Operations in action in new processing suites.

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276 Volume 66: Issue 6 I November/December 2012 www.engineersjournal.ie

tech talks – this programme has proven to be a beneficial XX

tool for knowledge sharing at both sites and across sites.

c) Fostering creativity/innovationThis is integrated into its Lean manufacturing approach, which focuses on people and continuous improvement. A number of the tools used in this process continuously are Kaizen, Mistake Proofing, Gemba and 5S. These have been utilised to influence the culture within the organisa-tions in support of creative and innovative thinking. This approach is integrated into its project approach, which has been successful in delivering innovation in the projects outlined above.

d) Performance management and development systemEmployees were seconded to projects and given the opportunity to break away from their day-to-day jobs. Goals and objectives were filtered down from the Janssen Ireland cascade to individual employees PC and D (performance, coaching and development), which ensured that there was benefit to both the company and the employee. This allowed employees to develop new skills, expand their experience and participate in project that were key to ensuring the sites can produce a sustainable product base.

e) Linkages with professional institutions/learned bodiesIn-house engineers or process specialists working on project designs utilised the knowledge base of multiple professional bodies such as

Engineers Ireland, IChemE, ISPE and IMB (Irish Medicines Board); as well as J&J worldwide engineering forums such as ‘Engineering Network’.As part of an Enterprise Ireland programme, Janssen partnered with ABB and UCD (University College Dublin) on PAT (Process Analytical Technology) and control systems. Janssen runs an apprenticeship programme and students from FÁS on work placement were given work experience as part of the clinical suites project team. The Solid State Pharmaceutical Cluster, funded by Science Foun-dation Ireland and by industrial partners, including Janssen, was established in 2007 to address significant industry challenges and supports research in process crystallisation, particle engineering and API/Postgraduate educational activityBy utilising Janssen’s Further Education Assistance Programme, a number of engineers and scientists have been supported by Janssen to attain a higher level of education in support of their develop-ment opportunities. A number of personnel who have completed this programme have obtained lead roles in the projects outlined above. Clinical product and sterile API manufacturing requires a lot of scien-tific and technical support for development, testing and analysis of clinical trial batches and optimisation of commercial manufacturing. The company uses its linkages with educational bodies such as UCC, CIT, UCD, UL, Sligo IT and IT Tallaght; to give graduate positions and work experience to many engineers and scientists.

Aseptic Processing Suite at Janssen Pharmaceutical, Little Island.

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Janssen has an in-house PDMS group, consisting of highly educated scientists. Having this knowledge and skill base located in Cork was a deciding factor in locating the clinical suites in Cork, and for the future ensures that there is much local support for product development and optimisation of existing and future commercial products.The J&J Global Operations Leadership Development Programme is a dynamic two-year programme for high-potential candidates with exceptional drive and determination. Individuals who have recently received undergraduate degrees in engineering, operations, or qual-ity can develop and apply their skills through a mix of on-the-job assignments and structured training, and some of these people have been deployed to work on the projects featured in this article.

Business benefitsThe success of the change in business strategy for both facilities has delivered on the opportunity for people development, leading to retention of staff and the creation of jobs in Janssen Ireland over the past 24 months. This supports the effective impact of its CPD mission of ‘attract, motivate and retain’ to-date.For Janssen, the continued reduction in cost of goods produced allows the Cork sites to be competitive and viable. Delivering incremental volumes, with the resultant absorption of costs and a controlled headcount increase has put Janssen Ireland in a very strategic posi-tion. This has been achieved while maintaining its key performance indicators and ensuring compliance delivers on its ‘right to exist/produce and sell’ within a culture of continuous improvement driving the company’s sustainability into the future.

The Engineers Ireland CPD Company of the Year Awards are supported by:


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