- Provide the day-to-day IT Support. | - Response to all end user inquiries toward the IT engagement model via IT phone, direct contact and IT service management tool. | - Operate the Incident Management and Service Requests fulfillment processes in our IT service management tool. | - Facilitate Critical Incident for minimum disruption of the business. | - Manage On/Off boarding of end users’ devices, resources, and accesses incl. introduction to IT. | - Procure and ensure local IT equipment availability and local IT storage management. | - Interface with Global cross functional teams to coordinate, standardize and optimize support effort. | - Collaborate with cross functional teams to support and improve IT services. | - Participate/contribute to problem and IT Knowledge management. | - Participate in IT project on a business need basis. | - Participate in On Call rotary.
- Proactively manage and report project costs to within the allocated budget | - Chair regular Project Progress meetings with the Client and Sub-Contractors. Attend regular Capital Projects Team and Tier meetings | - Responsible for stakeholder management on the project. Ensuring that clear lines of communication are maintained throughout | - Responsible for managing the project risk register and implementing risk mitigation strategies | - Proactively highlights risk including but not limited to safety, budget, schedule and quality.
- Proactively manage and report project costs to within the allocated budget | - Attend regular Capital Projects Team and Tier meetings | - Maintain good working relationships with customers and subcontractors involved in delivering the project | - Responsible for raising projects risks and implementing the agreed mitigation strategy | - Proactively highlights risk including but not limited to safety, budget, schedule and quality
| - Responsible for the creation, management and governance of the IT/OT architecture, strategy and 5-year roadmaps. Responsible attending the global FDB Architectural Review Board (ARB) to ensure standards and alignment are maintained. (10%) | - Perform cross-functional, multidisciplinary technical oversight to include evaluation of project work, staff, methods, and associated procedures related to enterprise-level IT/OT systems. Compile technology related documentation for GxP and critical IT technologies. Participate in system validation and testing processes as required. Approve validation documentation together with relevant ITQ. Represent IT system in connection with audits and inspections. (40%) | - Consult with system administrators, vendors, and other department personnel to provide guidance and technical direction for proposed enterprise technical solutions ensuring alignment with overall business strategy and vision statements (15%) | - Design enterprise-wide systems architecture and integration strategies across multiple platforms, technologies, or software systems. (35%)
- Review and investigate key equipment failures and maintenance trend data to determine suitable preventive actions against recurring failures. Champion the 5C process for investigation of equipment failures. Revise procedures and processes accordingly. | - Apply value analysis to make maintenance decisions to repair, replace or redesign. Identify equipment requiring excessive maintenance and take appropriate action to reduce it. Identify and remove non-value-adding maintenance activities or routines. | - Own and manage the seal change procedures and processes for site. | - Participate in review of new installations on the facility to ensure their maintainability and reliability. | - Provide mechanical technical support of maintenance activities on the facility. | - Manage or act as the customer for minor projects and improvement works to maintain the facility structure, fabric and finishes to an appropriate standard | - Present maintenance strategy and performance data during customer and regulatory inspections
- Ensure that maintenance work complies with statutory and local Engineering standards and requirements, using own knowledge and the support of other engineers. | - Perform fault diagnosis, maintenance and servicing work safely and efficiently in accordance with manufacturers' instructions. Read and extract information from engineering drawings, specification diagrams and maintenance manuals. | - Prepare the work area for maintenance of plant, systems or components. Reinstate the work area after completing the maintenance of plant, systems and components. Conduct safe and effective hand over of plant and equipment to others and accept and confirm responsibility for the control of plant and equipment within the work area isolation boundary. | - Use site cGMP systems and the SAP system to ensure all maintenance documentation is completed and archived in accordance with site procedures. | - Technically and accurately complete calibration and test documents to assure compliance and technical sign off.
- | Carry out day to day maintenance activities on the Billingham site as part of a multi-skilled maintenance team. | | - | Reporting to the Technical Engineer (Mechanical) and working closely with the maintenance planning team, the individual will perform routine planned works and respond to breakdowns within cGMP assets and all support facilities | | - | Ensure that maintenance work complies with statutory and local Engineering standards and requirements,usingownknowledge andthesupportofother engineers. | | - | Perform fault diagnosis, maintenance and servicing work safely and efficiently in accordance with manufacturers' instructions. | | - | Read and extract information from engineering drawings,specificationdiagramsand maintenancemanuals. | | - | Prepare the work area for maintenance of plant, systems or components. | | - | Reinstate the workarea after completing the maintenance of plant, systems and components. | | - | Conduct safe andeffective hand over of plant and equipment to others and accept and confirm responsibility for thecontrolofplantandequipmentwithin theworkareaisolationboundary
- Responsible for testing, recording, evaluating, and reporting of microbiological quality data and contamination control of all FDBK cleanroom facilities and water systems. | - Short and long term work load planning of QC Facility Microbiology Team and ensure samples are taken in accordance with procedure. | - Respond to trends in facility performance, system suitability or sample acceptance failures and perform root cause analysis to decrease negative trends within the team. | - Able to plan, prioritise and change priorities in very short timelines as business needs change. | - Assist in QC laboratory investigations, deviations and root cause analysis.
- Member of Site Senior Leadership team reporting directly into the Head of Site. | - | Ensure all commercial and clinical products manufactured are safe for human use, by the implementation and auditing of GMP procedures and practices. The job holder will be the nominated FDBK Production Manager on all site MHRA licences held for MF1,2,3, 4, 5 and MCC & Borealis manufacturing. | | - | Set and deliver the operations fixed costs budget, to deliver maximum business benefit from the installed assets. Track and deliver fixed cost and performance targets for manufacturing operations ensuring that FDB management is informed of a latest view and corrective actions are identified and taken when required. | | - | Define and deliver the incremental change programme for the operations team, maintaining consistency with strategic changes driven by the development of a large-scale commercial manufacturing capability. | | - Own and communicate the Operations vision for FDBK, creating a strategy to balance the demands of business as usual and expansion projects. | - Ensure operations at all timeshave an up-to-datepre-approval inspection readiness plan in place. | - Lead and develop high standards of Safety, Health and Environmental practice within all areas of responsibility. | - Maintain and improve thesite right first-time manufacturing performance through effective and appropriate people management and training. | - | As a member of the Site Leadership Team contribute to the site goals and objectives to ensure the long-term success of FDBK. | | - Ensure the sustainability of themanufacturing & supply chainteams by having an effective succession plan which identifies key talent within the team. | - | Creating policies and practices that will have a long-term impact on the organisation’s success
As the Senior AI Engineer, you will be responsible for developing and deploying artificial intelligence and machine learning models. You will work closely with data scientists, software developers, and business analysts to design intelligent solutions that enhance our products, services, and operations. Simplicity and adaptability is important in everything we do! | | Principal Accountabilities: | - Model Development: Design, develop, and implement machine learning and AI models to solve business problems | - Data Preparation: Collaborate with data engineers to ensure data is prepared and curated for model training, including data cleaning and feature engineering | - Integration: Work with software engineers to integrate AI models into existing or new applications using APIs or other integration methods | - Testing & Evaluation: Conduct rigorous testing and evaluation of models to ensure accuracy, efficiency, and scalability, and refine models based on performance metrics | - Deployment: Deploy AI models into production environments, monitor their performance, and iterate based on user feedback and business needs | - Collaboration: Collaborate with cross-functional teams to identify AI opportunities and provide technical expertise | - Research: Stay up-to-date with the latest advancements in AI technologies and methodologies and apply them where applicable | - Documentation: Document model designs, development processes, and integration workflows for future reference | - All other duties assigned
- Develop and continuously maintain an updated modality strategy based on market insights, detailing and recommending where FDB should position itself and how to grow profitability within the modality. | - Provide insights on market, competitors, and customer needs to identify business synergies, opportunities, dependencies, improvements, market expansions, or acquisition targets that address roadmap strategy and provide a competitive advantage within the modality. | - Ensure all operational, marketing and commercial efforts are aligned, customer-centric and deliver value to the target audience and meet sales and profitability goals. | - Present business case, strategy, and future roadmap recommendations, to the Strategy Decision Forum and ELT for input and approval, including investment requirements. | - Collaborate with cross functional teams to ensure successful prioritization and implementation of aligned tactics in support of the approved modality strategy and roadmap. Develop and socialize a launch playbook to train internal teams on the approved strategy and tactics. | - Ensure organizational alignment between the modality strategy, kojoX and our Partners for Life strategies. | - Ensure modality roadmap priorities reflect and are revised for continuous improvement to account for market, customer and competitive insights. Ensure roadmap priorities are reflected in innovation, business development, and marketing strategies. | - Define, deliver, and optimize modality strategy value proposition with the Marketing and Commercial teams to ensure alignment with customer segmentation, go-to-market strategy and tactics. Create evidence-based proof points and case studies that differentiate our offerings. | - Collaborate with our Business Development team on business expansion initiatives; perform gap analyses to determine where the Company can become more competitive and how we strengthen our overall business strategy. | - Support the development and implementation of dedicated marketing and commercial strategies that align with the overall modality strategy and business goals. Collaborate with commercial to ensure a robust sales pipeline that can fill the service line manufacturing capacity (short, mid, and long term). | - Participate in strategic commercial dialogues with key partners and provide technical expertise to sales teams and customers as needed. | - Create, maintain, and continuously improve modality roadmaps to ensure alignment with market, customer and competitive insights, capacity of operational footprint and budgets. | - Drive P/L (Revenue, ROS, PM, EBITDA etc.) transparency and insights for continued financial performance improvement. | - Track and report operational performance (KPIs) to ensure high customer trust and satisfaction. | - Collaborate as needed to develop key areas of improvement and focus to deliver the Partners for Life strategy, with an ongoing engagement of and partnership with ELT. | - Provide modality strategy and life cycle management and lead new service line offering development through leadership of a cross-functional team. | - Perform other activities as assigned. |