Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drugs, undergoing a major expansion of its biologics facility in Ireland
The Automation Lead will lead, mentor and manage the automation activities and allocated resources for our new State-of-the-art- single use multi-product biotech facility in Ireland. This facility will manufacture enzyme replacement and antibody-based therapies.
Key responsibilities will include the management of automated systems, processes and project resources, building and process automation systems (BAS and PAS), manufacturing execution system (MES). Hire and build team capabilities to optimise automated processes and drive future breakthrough business solutions. This is a key role at the plant within the Site Engineering organisation to help create value for our patients.
- Provide strategic leadership and management for Automation activities at the Biologics start-up facility to meet functional and site objectives.
- Responsible for Automation Engineering Function including PAS, BAS, MES, Siemens PLC platform, Delta V Distributed Control System, PI Historian, PLC/SCADA, Integration of CMMS, hardware and software specification, code review and control, OEM’s, System Integration, own designated Servers, Vendor Management, record and data management, and budget management.
- Responsible for leading the implementation of Best-Known-Methods in Automation, design and implementation of Plant Automation Strategy, Life-Cycle Management of Automated Systems, equipment servicing and performance management, records and data management and budget management.
- Participate, influence and implement automation strategies that deliver business efficiency, growth, process optimisation and ongoing enhancements.
- Understand current system design and partner with key stakeholders (Global Manufacturing and Engineering Services, Enterprise Application Services, Quality Systems, Global Automation, Global IT, Infrastructure Services, and key vendors) to deliver 'futureproof' innovative and proven solutions to ensure ongoing effective delivery of operations.
- Responsible for generating all Automation related documents, specifications, and for standing-up the Automation Systems at the plant, 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.
- Working with Global Engineering and IT teams to design, implement, deliver and sustain best-in-class Automation Management Systems to ensure robust system performance, whilst evaluating and developing edge-of-next technology platforms appropriate for the site.
- Enshrines safety, quality and operational excellence culture as a value within the Automation Team and ensures that these programmes are sustained.
- Build a high performance multi-skilled automation team and culture through effective talent acquisition, onboarding process, training programme and guides.
- Leads the Automation 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.
OPERATIONAL AND TECHNICAL SUPPORT
- Provide automation and technical support to ensure stable, efficient and robust operations at the site.
- Responsible for designing and deploying a best-in-class automation programme for the site.
- Develop and manage escalation plan for routine and out of hour’s emergencies, and response for automation team.
- Execute selection and manage automation service contractors and suppliers to ensure effective services, cost, and compliance with Company requirements.
- 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.
- The Automation Lead will collaborate with Manufacturing, Facilities, Process Development, Quality Assurance, EHS, Global Engineering, Maintenance, Validations and Engineering teams in developing requirements and recommendations for system modifications, upgrades, retrofits and replacements.
- Manage the automation projects and Shires maintenance programmes by following a systematic approach in accordance with financial and business requirements.
- Accountable for the design, commissioning and delivery of automation projects.
- Provide appropriate leadership and structures to ensure plant automation design, commissioning, qualification and validation is executed per requirements.
- Develop and implement robust processes to drive an environment of right-first-time.
- The Automation Lead will utilise Operational Excellence tools and techniques in completing designs, implementing technical solutions and resolving complex problems.
- Strengthening the overall engineering leadership and organisational capabilities in area of responsibility.
- Establish and maintain best-in-class automation systems, process and methodologies around the management of automation specifications, GEP, reliability and technologies and the integration of a highly automated operating model across the site.
- A minimum of a Bachelor degree in IT, Mechatronics, Electronics, or equivalent.
- 10+ year’s relevant industry experience in the Biopharma/Pharma sector.
- Has working knowledge of FDA, HPRA, GMP, 21CFR11, safety and environmental requirements and regulatory inspections.
- 8+ years leadership experience – direct reporting with demonstrated ability to motivate and develop team.
- Systems background: BAS, PAS, ERP, MES, Data Historian (OSI PI), Data Integrity, SCADA, Siemens PLC an advantage.
- 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 automation practices.
- Strong operations support background ensuring value added and effective automation contribution and oversight.
- Must be a team player prepared to lead, work in and embrace an interdependent working culture.
- A relevant postgraduate qualification in life science, business or reliability engineering is desirable.
- Operational Excellence/ Lean Six Sigma qualification or competency in leading, training and/or implementing root cause analysis and effective investigation practices.
- Track record of effective automation leadership in a multi-national organisation.
- A background of working in advanced automated manufacturing operations with integrated sophisticated processes.
Key Skills and Competencies
- Living our leadership behaviours is a basic expectation for all employees. Company expects all employees to embody the following:
- Be Positive
- Be Accountable
- Be Results Oriented
- Be an Excellent Manager of Self and Others
- 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 Automation team and to internal/external stakeholders to ensure excellence around collaboration and the creation of an interdependent operating culture.
- Be an ambassador for Company 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 Guide for ethical conduct.
- Strengthening the overall automation leadership and organisational capabilities in area of responsibility.
- Ability to translate the vision and goals of the company and site to the automation 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 automation team.
- 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.
- 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 automation group.
Internal and External Contacts
- Build partnerships with the Global Biologics Engineering and IT Leadership Team (BELT) to create and sustain a culture that demonstrates excellence and sets the benchmark in maintenance, continuous improvement and current best practices.
- Execute selection and manages service contractors and suppliers to ensure effective services, competency level, cost, and compliance with Company 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 Automation Engineering organisation.
- Collaborates with the Global Engineering/ IT 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.
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