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Shire Senior Reliability Engineer in Dunboyne, Ireland
The Senior Reliability Engineering will be responsible for designing and implementing the reliability programme for our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire, the leading global biotech company focused on rare diseases. The primary role will be to establish a world class reliability programme, lead the asset risk management process and provide technical training and coaching to the self-directed work teams.
This is an important role at the plant within the Site Engineering organisation to help create value for our patients.
TECHNICAL RELIABILITY ENGINEERING
Provide strategic leadership and oversight for Plant Asset Reliability activities at the Dunboyne Biologics facility to meet functional and site objectives.
Define, monitor and review the asset management plan including the standards and procedures for plant assets including the change management process to de-risk changes
Responsible for establishing the Reliability Asset Care program, developing technical standards, drafting SOP’s, designing the risk management process, ensuring right first time philosophy is integrated across the site and within the value-streams,
Ensuring that all reliability engineering methodology is included in the thinking of shutdown and energy conservation programmes.
Implementing the MRO system, vendor management, technical engineering report writing and budgeting for the asset care program at the site.
Ensures safety, quality and operational excellence is foundational within the Reliability Programme.
Subject Matter Expert and leader for the site reliability programme who works with cross-functional teams to ensure that there is an effective and robust asset utilisation and equipment reliability master plan developed and implemented at the site.
Responsible for generating all Plant Reliability documents, specifications, training programs, and for standing-up the Plant Reliability Systems, generating and managing Standard Operating Procedures, Protocols, Technical Reports and QMS reports.
Ensure that reliability and improvement projects are included in the capital plan.
Participate in the Site Operations Readiness team to ensure that that reliability Engineering methodology is fundamental in the design and is carried through the CQV planning and implementation.
Work with Plant Engineering Lead in establishing and meeting targeted site and Tech Ops objectives, ensuring department objectives are aligned, translated to all and visually managed to drive performance results.
Participate in performance review program and development plans.
Ensure that reliability and maintenance budgets are met and that annual efficiency targets are set and met.
OPERATIONAL AND TECHNICAL SUPPORT
Provide engineering and technical support to ensure stable, efficient and robust operations at the site.
Responsible for designing and implementing a best-in-class equipment reliability programme for the site.
Develop and manage escalation plan for reliability engineering program and develop a plan for out of hours support.
Support Manufacturing to ensure equipment remains in an operational state with minimal downtime. Troubleshoot equipment, process, facility and utility issues by performing investigations, root-cause analysis and implementing corrective and preventive actions.
Implement a reliability-based maintenance program for assets to ensure that spare parts inventories are appropriate to support manufacturing and prevent unplanned downtime.
Execute change control including writing and executing change control test plans.
Ensure we use various and conditioned based maintenance techniques (thermal imaging, temperature, pressure, oil viscosity, vibration analysis) to drive a predictive culture in our reliability programme.
Responsible for timely updates of achievements and challenges. Works collaboratively on resolving obstacles and building relationships so as to maintain a highly effective and productive work environment.
Execute capital and improvement projects by following a systematic approach in accordance with financial and business requirements.
Accountable for the design, establishment and execution of reliability projects.
Ensure that the reliability programme is appropriately structured, resourced and staff trained to meet their goals and objectives and ensure that improvement projects are delivered.
Provide appropriate technical input to ensure plant and equipment design, commissioning, qualification and validation is executed to reliability engineering standards.
Collaborates with Manufacturing, Facilities, Process Development, Automation, Quality Assurance, EHS, Global Engineering, Validations and Maintenance teams in developing requirements and recommendations for system modifications, upgrades, retrofits and replacements.
Will utilise Operational Excellence tools and techniques in completing designs, implementing technical solutions and resolving complex problems.
Establish and maintain best-in-class plant reliability engineering systems, process and methodologies around the management of assets and plant equipment in accordance with cGMP and GEP’s.
Education & Experience Requirements
Bachelor’s Degree in Mechanical or Reliability Engineering degree or equivalent.
At least 8 years’ experience in a manufacturing environment with 5 of these in pharmaceutical manufacturing, medical devices or equivalent.
Experience in leading, training and implementing root cause analysis and effective investigation practices in an Operational Excellence environment.
Proven ability in using a wide variety of lean tools and building capability within teams.
A relevant postgraduate qualification in reliability engineering, automation or TPM.
A background of working in advanced automated manufacturing operations with integrated sophisticated processes.
Key Skills and Competencies
Must be a team player prepared to lead, work in and embrace an interdependent working culture.
Proven ability around identifying and eliminating inefficiencies and implementing innovative technological solutions.
Excellent interpersonal and influencing skills.
Proficient knowledge of CMMS and engineering & maintenance business practices / procedures.
In depth working knowledge of laboratory and pharmaceutical production and support equipment, including utilities and critical systems (CIP, WFI, HVAC, Single-Use-Systems, plant and clean utilities).
Knowledge of chemical and biological safety procedures.
Experience with Reliability Centered Maintenance (RCM) and/or Total productive Maintenance (TPM)
Experience in process improvement and reliability engineering principles, methodologies and tools such as PDCA, LEAN, SixSigma / DMAIC, RCFA, FMEA.
Must be able to organize and present technical and project management plans and schedules without assistance.
Excellent organisational, verbal and written communication skills and demonstrated ability to communicate effectively with cross-functional teams, global teams and management.
Passion for Improving Lives, putting patients at the centre of everything we do.
Quest for Innovation. Must be able to operate with agility and a learning mind-set so that we can accelerate breakthrough innovations.
Demonstrated ability to thrive in high performing team environment.
Ability to embrace change and seek diverse perspectives and partnerships to benefit patients and make a positive impact on the world.
Proactive at keeping current with the latest technologies and engineering practices.
Shire expects all employees to embody the leadership behaviours of:
Be Results Oriented
Be An Excellent Manager of Self and Others
Creates a positive, performance driven environment through lean leadership, robust knowledge management and communication planning.
Provides direction, guidance and technical support to internal/external stakeholders to ensure excellence around collaboration and the creation of an interdependent operating culture.
Be an ambassador for Shire leadership behaviours of accountability, be positive, results driven and excellent manager of self.
Role model behaviours that creates a culture of respect and dignity in line with the Shire Guide for ethical conduct.
Ability to translate the vision and goals of the company and site to key stakeholders of the Reliability Engineering programme.
Enterprise mindset to ensure the right prioritization for the site.
Strong project management skills to support project delivery and operational readiness.
Excellent influencing/collaboration skills and teamwork mind-set.
Demonstrated trouble shooting and problem solving skills as well as an ability to coach and mentor others through complex problems.
Ability to challenge the status quo with a continuous improvement mind-set.
Change agent who will support the organisation with effective change management tools and techniques.
Promoting a culture where diversity and inclusion is the norm.
Other Job Components
Complexity and Problem Solving
- Establishes challenging assignments and stretch goals for self and cross-functional team members and provides guidance to team members on prioritization and resource allocation to achieve goals in accordance with established polices and business needs.
Internal and External Contacts
Build partnerships with the Global Biologics Engineering Leadership Team to create and sustain a culture that demonstrates excellence and sets the benchmark in reliability engineering, continuous improvement and current best practices.
Execute selection and manages service contractors and suppliers to ensure effective services, competency level, cost, and compliance with Shire requirements.
For safety and quality, the individual is accountable to drive a culture of ‘everyone owns safety and quality’ with input from the Quality and EHS Leads.
Collaborates with the Global Engineering COE and external technical forums to ensure delivery of the objectives, best practices and business excellence.
Ability to work in fast-paced dynamic environment and handle multiple tasks simultaneously.
Limit travel 5% required.
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Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.