Shire Plant Engineering Operations Lead in Dunboyne, Ireland
The Plant Operations Engineering Lead will lead, mentor and manage the engineering activities and allocated resources for our new start-of-the-art- single use multi-product biotech facility in County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for Shire, the leading global biotech company focused on rare diseases. Key responsibilities will include the management of plant engineering systems and processes, reliability engineering programme, GMP-utilities, plant equipment, project engineering and technical support. This is a key role at the plant within the Site Engineering organisation to help create value for our patients.
Provide strategic leadership and oversight for Plant Engineering Operations activities at the Piercetown Biologics facility to meet functional and site objectives.
Responsible for the Plant Engineering Operations function, manufacturing system engineering, GMP-utilities, plant equipment, HVAC, WFI, Boilers, CIP skids, reliability engineering, maintenance excellence programme, capital projects, project engineering, equipment improvement projects, shutdown management, engineering drawings and specifications, engineering technology, vendor management, technical engineering reports, site master planning, record and data management, and budget management.
Enshrines safety, quality and operational excellence culture as a value within the Plant Engineering Operations Team and ensures that these programmes are sustained.
Build a high performance team and culture through effective talent acquisition, onboarding process, training programme and guides for plant engineering.
Responsible for generating all Plant Engineering related documents, specifications, and for standing-up the Plant Engineering Systems, generating and managing Standard Operating Procedures, Protocols, Technical Reports and QMS reports.
Key participant on the site operations readiness team interfacing with the projects team to ensure that the project is delivered in accordance with the agreed scope.
Manage the lifecycle process for installed assets ensuring maintenance excellence and reliability engineering expertise support for process, plant, facilities equipment and associated systems.
Leads the Plant Engineering Operations department 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.
Conducts performance reviews, development plans for self, reports and department.
Develops monitors and appropriately adjusts the annual budget for the department.
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 routine and out of hour’s emergencies, and response for plant engineering team.
Active participation in the commissioning, qualification and validation programme.
Maintains the plant engineering areas in an inspection-ready, GMP compliant state.
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.
Manage the capital and projects engineering programme by following a systematic approach in accordance with financial and business requirements.
Accountable for the design, commissioning and delivery of plant engineering projects.
Ensure that project support teams are appropriately structured, resourced and trained to meet their goals and objectives and ensure that projects are delivered on time and within budget.
Provide appropriate leadership and structures to ensure plant and equipment design, commissioning, qualification and validation is executed per requirements.
The Plant Engineering Operations Lead will collaborate 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.
The Plant Engineering Operations Lead will utilise Operational Excellence tools and techniques in completing designs, implementing technical solutions and resolving complex problems.
Establish and maintain best-in-class plant engineering systems, process and methodologies around the management of engineering drawings, GEP, specifications, reliability and equipment programs and the integration of a highly automated operating model across the function.
Education & Experience Requirements
A minimum of a Bachelor’s of Engineering degree or equivalent.
At least 10 years’ experience in the biologics and/or pharmaceutical manufacturing.
Proven people manager and leader capable of developing people and teams with at least 8 years of management experience.
Five (5+) plus years of effective management of engineering personnel in a matrix multi-national organisation.
Proven ability around identifying and eliminating inefficiencies and implementing innovative technological solutions.
Proactive at keeping current with the latest technologies and engineering practices.
Strong operations support background ensuring value added and effective engineering contribution and oversight.
Must be a team player prepared to lead, work in and embrace an interdependent working culture.
A relevant postgraduate qualification in reliability engineering, automation or TPM is desirable.
Operational Excellence/ Lean Six Sigma qualification or competency in leading, training and/or implementing root cause analysis and effective investigation practices.
A background of working in advanced automated manufacturing operations with integrated sophisticated processes .
Key Skills and Competencies
Fosters a diverse workplace that enables team members to contribute to their full potential in pursuit of organisational objectives.
Creates an entrepreneurial positive, performance driven environment through lean leadership, robust knowledge management, talent reviews and communication planning.
Provides direction, guidance and technical support to the Plant Engineering Operations team and 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 and others.
Role model behaviours that creates a culture of respect and dignity in line with the Shire Guide for ethical conduct.
Strengthening the overall engineering leadership and organisational capabilities in area of responsibility.
Ability to translate the vision and goals of the company and site to the Plant Engineering Operations teams.
Enterprise mind-set to ensure the right prioritization for the site.
Strong project management skills to support project delivery and operational readiness.
Strong stakeholder management skills to manage both internal and external stakeholders that support the site.
A proven ability to lead a complex Plant Engineering Operations group.
Excellent influencing/collaboration skills and teamwork mind-set.
Demonstrated trouble shooting and problem solving skills as well as an ability to coach and mentor teams through complex problems.
Ability to challenge the status quo with a continuous improvement mind-set.
Proven ability in using a wide variety of lean tools and building capability within teams.
Change agent who will support the organisation with effective change management tools and techniques.
Strong Talent Developer with a focus on creating a continuous learning organisation through active coaching.
Effective communicator with a proven ability to grow talent and future leaders.
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 team members and provides management and guidance to team members on prioritization and resource allocation to achieve goals in accordance with established polices and business needs.
Identifying and communicating risks in area of responsibility and across the site.
Creating strategies and plans to manage risk within the engineering group.
Internal and External Contacts
Build partnerships with the Global Biologics Engineering Leadership Team (BELT) to create and sustain a culture that demonstrates excellence and sets the benchmark in 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 Global Engineering, Business Excellence and Human Resources in the delivery of the people strategy including recruitment, learning and development and organisational talent reviews to develop a high performing Engineering organisation.
Collaborates with the Global Engineering team and external forums to ensure delivery of the objectives, best practices and business excellence.
Ability to work in fast-paced environment and handle multiple tasks simultaneously.
Limited travel 5% required.
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.