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 Process Engineering Lead will lead, mentor and manage the process engineering 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 process engineering systems (upstream and downstream) around the equipment design, specification and performance, generation of technical reports, process modelling, risk management and integration of process equipment systems. Hire and build team capabilities to optimise process equipment and to develop future breakthrough business solutions. This is a key role at the plant within the Engineering organisation to help create value for patients.
- Provide strategic leadership and oversight for Process Engineering activities at the Biologics start-up facility to meet functional and site objectives.
- Responsible for the Process Engineering Function, acting as the SME to manage the design, specification, selection, equipment performance, engineering CQV, technical drawings, maintenance reliability of process equipment, vendor management, an engineering assessment of changes, conducting/leading investigations, forward planning and budget management.
- Responsible for generating all Process Engineering related documents, specifying functional requirements, and for standing-up the Process Engineering Systems and Programmes, generating and managing Standard Operating Procedures, Protocols, Technical Reports and QMS reports.
- Lead and support the integration of process engineering systems, utilities, and automated and single use components to ensure a robust and reliable manufacturing operation.
- Specify the functional requirements for the process automation systems and work collaboratively with the process automation team to ensure that the automation functionality meets the process and business needs.
- Enshrines safety, quality and operational excellence culture as a value within the Process Engineering 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 Process Engineering related documents, specifications, and for standing-up the Process 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 process equipment and single-use-system assets ensuring maintenance excellence and expertise support for the equipment and associated systems.
- Leads the Process Engineering 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 process engineering and technical support to ensure stable, efficient and robust operations at the site.
- Support the operations team in maintaining an effective lifecycle process for process-equipment/assets ensuring maintenance excellence and robust reliability programme.
- Own the installed process equipment with respect to technical capability, functionality, yield/output and OEE performance.
- Establish and manage an ongoing improvement plan to rationalise the process, drive value and improve efficiencies.
- Develop and manage escalation plan for routine and out of hour's emergencies, and response for process engineering team.
- Active participation in the commissioning, qualification and validation programme.
- Maintains the process 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.
- Accountable for the design, commissioning and delivery of process engineering projects.
- Ensure that process engineering 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 process equipment design, commissioning, qualification and validation are executed per requirements.
- The Process Engineering 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 Process Engineering Lead will utilise Operational Excellence tools and techniques in completing designs, implementing technical solutions and resolving complex problems.
- Establish and maintain best-in-class process engineering systems and methodologies around the management of specifications, reliability and equipment programs and the integration of a highly automated operating model across the function.
A minimum of a Bachelor of Engineering degree, preferably in Chemical Engineering or equivalent.
At least 8 years' experience in the biotechnology and/or pharmaceutical industry.
Proven people manager and leader capable of developing people and teams with at least 5 years of management experience.
Proven ability around identifying and eliminating inefficiencies and implementing innovative technological solutions.
Proactive in 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 Bioprocess Engineering, automation 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.
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. The company expects all employees to embody the following:
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 Process Engineering team and to internal/external stakeholders to ensure excellence in 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 Company 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 Process Engineering teams.
Enterprise mindset 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 Process Engineering teams.
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.
A 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 process 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 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 Process 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.
Cv to Gerry Kennedy Director at The RFT Group at email@example.com /01 2302400/ www.rftgroup.ie