I

ISSN 0332-1711
Volume 66: Issue 6 November/December 2012
www.engineersjournal.ie

www.engineersjournal.ie

Janssen Ireland
Engineers Ireland CPD Company of the Year 2012
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Chain reaction
Janssen Biologics Facility, Ringaskiddy

Janssen transforms Cork facilities for new era in pharma

The 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

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 pharma
The 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
 www.engineersjournal.ie Volume 66: Issue 6 I November/December 2012
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 strategy
The 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:
XX utilisation of the unused manufacturing capability of Janssen
Ireland to commence manufacture of new development/toxico-
logical and clinical phase (Phase 1 – 3) drugs;
XX re-engineering of the site facility to be capable of multi product
production;
XX organising two new small-scale toxicology/development/clini-
cal upstream and downstream suites (within the confines of
the existing manufacturing floor space) to produce early phase
273
material;
XX maximising use of new technologies to minimise costs and cycle
times e.g. disposable technologies;
XX moving early stage production (development/toxicological and
clinical phase) to Janssen Biologics resulting in minimising the
risk and cost associated with the technology transfer step at a
later stage; and,
XX relocating of process development and material sciences
(PDMS) analytical laboratory to Cork to support product tech
transfers.
The Janssen Pharmaceutical strategy
The 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:
XX increasing the capacity occupancy for sterile API’s from 30 per
cent to 90 per cent thus consolidating the facility as the primary
manufacturer of sterile API within the global network; and,
XX achieving regulatory approval for campaign manufactur-
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) processes
The 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
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

Organisational
Culture
Performance
& Recognition

Personal Employee Business

Development Attract
Business & Career
Strategy Motivate
opportunity
Retain
+ Satisfaction &
Engagement
Performance
& Results

Human Compensation
& Benefits
Resources
Strategy

Collaboration Employee Involvement

Cornerstones of the CPD process.
relevant extract from the CPD policy states: “The
company also benefits from employees’ CPD as it
feedback & coaching
leads to the achievement of world class standards in,
for example, quality, environmental, health and safety
(EHS) management, maintenance and engineering excel-
other activities
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-
70%
on the job
ing talented workforce to work on these projects,
20%
allowed Janssen Ireland to have a considerable
advantage by having an on-tap range of the required
10%
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 CPD
In 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:
XX a tailor-made course was designed and delivered in

Members of the Janssen CPD Team.

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collaboration with IT Tallaght to effectively train employ-

ees in sterile manufacturing/aseptic techniques;
XX a customised automation course was developed by Jans-

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,
XX Dynochem-user training was organised by Janssen to train

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 activities

Janssen Ireland has employed a number of knowledge sharing activi-
ties including:
XX a formal mentoring process (as part of the company’s

business objectives, initiated and driven from the CPD

committee, a mentoring programme is now active);
XX accelerated learning unit (ALU) – ALUs are used to optimise

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 Operations in action in new processing suites.
implement improved and more efficient site processes; and,
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Aseptic Processing Suite at Janssen Pharmaceutical, Little Island.
XX tech talks – this programme has proven to be a beneficial
tool for knowledge sharing at both sites and across sites.
c) Fostering creativity/innovation
This 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 system
Employees 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 bodies
In-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 activity
By 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.
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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 benefits
The 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: