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Job locations UK-Billingham
ID 2024-3101
Responsibilities
Provide daily, proactive, and efficient secretarial and administrative support to the Senior Leadership Team (SLT). |   | Line management responsibilities for two receptionists to ensure that the professional image and reputation of the company is upheld. Ensure that reception deliver appropriate administration services to the site as and when required. |   | Key point of contact for the SLT; prioritise and proactively manage internal/external enquiries and communications sent to directors and senior managers, some of which may be sensitive and/or confidential nature. |   | Proactive diary management for the SLT and Global employees as required including liaison with high profile personnel to ensure effective use of time. |   | Support SLT and management teams by preparing them for meetings, providing all supporting information and documentation such as agendas, minutes, papers etc. If requested, take, and type up minutes of meetings and co-ordinate post meeting correspondence and follow up actions. Collation of reports and presentations as required. |   | Management of ad-hoc business expenditure on the company purchasing card including reconciliation of costs. |   | Support and assist other team members to achieve smooth running of business operations, including the issuing and obtaining of necessary signatures. |   | Responsible for ensuring the reception desk is always occupied, including cover during periods of receptionist absences.
Category
Business Support
Type
Full Time
Worker Type
Permanent
From
GBP £29,963.00/Annual
To
GBP £45,684.00/Annual
Job locations UK-Billingham
ID 2024-3095
Responsibilities
- Represent all of Quality at the program level. | - Responsible for all Quality activities relating to the programme ensuring they are completed in the required timelines and in accordance with cGMP quality systems. | - Own S&OP business milestones for projects, provide timely identification and escalation of at risk milestones using business tools (eg: Gantt charts, trackers, risk assessments, etc) and drive remediation or mitigation. | - Drive the programme within Quality from kick off through to disposition. | - Guide and/or author the generation of key Quality documentation to support manufacture of Product (eg: cell bank, drug substance, etc). | - Ensure that all GMP documentation is in place, accurate and ready on time for GMP manufacture and linked activities. | - Escalating concerns early to enable timely changes. | - Review and approve quality documentation such as Product specification, customer’s regulatory submissions, qualification and validation protocols and reports. | - upport Quality/Manufacturing at client audits and during regulatory inspections for all details relating to Quality/Manufacturing activities, facilitating SMEs from the department to be introduced as required. This may include external auditing. | - Ensure programme reviews take place follow GMP manufactures, identify any learning is captured, communicated and actions put in place to make identified improvements across Quality/Manufacturing. | - Ensure change in scope of a manufacturing programme is raised to the Programme Manager and only progressed once approved (i.e. via a programme amendment order). | - Overcome technical problems by scientific understanding, options assessment and application of novel and innovative solutions.
Category
Quality Assurance
Type
Full Time
Worker Type
Permanent
From
GBP £40,000.00/Annual
To
GBP £44,000.00/Annual
Job locations UK-Billingham
ID 2024-3094
Responsibilities
- | To provide reliability, leadership, and expertise in CMMS. Working closely with the maintenance and manufacturing teams the role initially involves a project role to support to the start-up of the Borealis | | - | Flexible Cell Culture Facility (FCCF) project, developing Global methodologies and then transitions into the business-as-usual team. | | - | The role involves developing, owning, and managing the maintenance management system to ensure calibration, equipment and maintenance plans are accurate. Driving and owning the continuous improvement of the CMMS. | | - | Providing support to ensure the team are trained and able to effectively operate within the CMMS boundaries. | | - | Be the subject matter expert for maintenance on the CMMS (SAP) system. | | - | Own the policies, operation procedures and work instructions for FDBK CMMS. | | - | Use expert knowledge and LSS skills to lead SAP maintenance change projects with the aim to facilitate positive changes of the SAP system. | | - | Initially develop the introduction of work centres and assignment of tasks to individuals within the CMMS. | | - | Ensure that CMMS (SAP) accurately reflects the statutory and regulatory requirements of the business.
Category
Operations
Type
Full Time
Worker Type
Permanent
From
GBP £37,521.00/Annual
To
GBP £60,972.00/Annual
Job locations UK-Billingham
ID 2024-3093
Responsibilities
- | To provide technical support in the fields of Control, Electrical, Instrumentation, focusing on areas of personal technical expertise. | | - | Instrumentation and control focused post holders will support compliant manufacture of medicines by ensuring that calibration processes are effective, efficient, continuously improved and maximise manufacturing output by providing high availability and low failure rates of instrumentation. | | - | Line Manage team of C,E&I Technicians with a focus on safe behaviours, training and competency standards and performance. | | - | All post holders will be expected to demonstrate some cross functional support throughout the CEI field.
Category
Operations
Type
Full Time
Worker Type
Permanent
From
GBP £48,000.00/Annual
To
GBP £53,000.00/Annual
Job locations UK-Billingham
ID 2024-3092
Responsibilities
- To maximise asset availability by ensuring that maintenance techniques are effective, efficient and continuously improved. | - To provide technical support in the Mechanical maintenance fields, focusing on areas of personal technical expertise. | - Mechanical focused post holders will support compliant manufacture of medicines by ensuring that mechanical processes are effective, efficient, continuously improved and maximise manufacturing output by providing high availability and low failure rates of services and equipment. | - Line Manage team of Maintenance Technicians with a focus on safe behaviours, training and competency standards and performance. | - Root Cause analysis | - Line Management | - Quality Investigations |  
Category
Operations
Type
Full Time
Worker Type
Permanent
From
GBP £48,000.00/Annual
To
GBP £53,000.00/Annual
Job locations UK-Billingham
ID 2024-3091
Responsibilities
Phase 1: | - Initially this will be a project role during the introduction of a new Flexible Cell Culture Facility (FCCF) at Billingham. | - The job holder will be responsible for the development and implementation of the procedures and ways of working that will support efficient and safe operation of warehouse logistics, material storage and movement within the facility, when manufacturing activity commences. |   | Phase 2: | - To lead members of the logistics team in the management and continuous improvement of the warehouse management and logistics services within the FCCF at Billingham. | - The focus for the Logistics Lead is on the FCCF warehouse services, procedures and control, storage, and movement of materials throughout the FCCF to include cold chain and VLM management. | - This role also includes the management of the materials staging and buffer storage area and finished goods store in FCCF. | - There is also interaction required with Supply Chain, L6 and Cannon Street, raw materials, and consumables warehouse.
Category
Operations
Type
Full Time
Worker Type
Permanent
From
GBP £40,000.00/Annual
To
GBP £45,000.00/Annual
Job locations UK-Billingham
ID 2024-3090
Responsibilities
Phase 1: | - Initially this will be a project role during the introduction of a new Flexible Cell Culture Facility (FCCF) at Billingham. | - The job holder will be responsible for the development and implementation of the procedures and ways of working that will support efficient and safe delivery of facilities support services and cleaning of offices, welfare, and GMP manufacturing areas, within the facility, when manufacturing activity commences. |   | Phase 2: | - To lead members of the Facilities and Cleaning team and liaise with and manage associated support services provided to the FCCF facility by the on-site Service Provider organisation in line with agreed SLA’s and Cleaning Schedules, whilst ensuring services are delivered efficiently, effectively and on time through best value and best practice, whilst identifying opportunities for continuous improvement in the day-to-day management of the environment within the FCCF at Billingham. | - The focus for the Facilities Lead is primarily on the GMP cleaning requirements for the Manufacturing Clean and Non-Clean Room environments. | - Ensuring cleaning and restocking of changing room facilities is carried out in line with the appropriately agreed SLA’s and Manufacturing team and GMP operational requirements.
Category
Operations
Type
Full Time
Worker Type
Permanent
From
GBP £40,000.00/Annual
To
GBP £45,000.00/Annual
Job locations UK-Billingham
ID 2024-3083
Responsibilities
- To ensure all analytical work undertaken is performed in accordance with cGMP quality system. | - Identify concerns with processes, methods or data and where possible develop or contribute to the development of solutions with management support. | - To ensure that all work undertaken complies with safety assessments contained with analytical methods and risk assessments. | - To follow plans & objectives set for the team. | - Maintenance of key lab systems and processes (e.g. KanBan, 5S, etc.). | - Good communication skills demonstrated within team. | - Flexibility to adapt to changing plans.
Category
Quality Control
Type
Full Time
Worker Type
Permanent
Job locations UK-Billingham
ID 2024-3079
Responsibilities
The Production Technologist responsibilities develop with experience ranging from New Start/Trainee to Senior Production Technologist. |   | For Project Borealis, there are 2 phases to the role; in phase 1 the successful applicant will join the Borealis project team and contribute to the set up of the facility, participating in preparation activities to ensure Borealis is operationally ready for December 2025, during phase 1 the role will be day shifts Monday – Friday. |   | Once the facility 'goes live' in phase 2, the Production Technologists will be responsible for the safe and compliant completion of GMP manufacturing activities, aiding in the delivery of the facility asset plan. In phase 2  the successful applicant will become part of a manufacturing team working shifts. Main duties include: |   | - Understanding and executing production plans with limited guidance | - Develop an understanding of the requirements of GMP (e.g. Purpose of a BMR, role of a Witness, Good Documentation Practice) and operation of the cGMP manufacturing facilities through designated training and On-the-job learning. | - Execution of manufacturing operations according to Electronic/ Batch Manufacturing Records (eBMR/ BMR) and associated Work Instructions. | - Ensure accurate management of Raw Materials and consumables in SAP | - Identify and appropriately report all potential safety risks and violations | - Identify and appropriately report all deviations from defined operating procedures
Category
Operations
Type
Full Time
Worker Type
Permanent
From
GBP £24,000.00/Annual
To
GBP £35,000.00/Annual
Job locations UK-Billingham
ID 2024-3068
Responsibilities
  | As a Principle Information Security Manager, you will be part of Global Information Security Office team within the FDB IT Department. You will work together with other highly | dedicated and skilled colleagues focused on the mission of ensuring a stable, efficient, and compliant IT services. Simplicity and agility is important in everything we do. |   | This post will work in close collaboration with the Global Head of Information Security Office and be instrumental in the delivery of a Global Information Security Management | System (ISMS) |   | Key responsibilities: | - Collaborating with the GHISO to develop and implement: FDB’s cyber security strategy. | - ISMS, Data Governance strategy, NIS2 compliance strategy. | - Assessing and managing cyber security risks. | - Ensuring organizations compliance with applicable regulations and standards. | - Ensure the smooth operation and security of all assigned systems/technologies. | - Collaborate with cross-functional teams to support and improve IT services.
Category
IT
Type
Full Time
Worker Type
Permanent
From
GBP £54,719.00/Annual
To
GBP £84,183.00/Annual
Job locations UK-Billingham
ID 2024-3059
Responsibilities
The Sr. Director Quality Management System (QMS) content owner is accountable to ensure that content of global QMS processes are compliant and designed proactively to support business aspirations (e.g. KojoX, digitalization and use of AI) and regulatory trends. In this role, you will be fully empowered to decide on design and enhancement of core processes and to recommend solutions for future QMS initiatives to drive compliance, business and operational improvements for the company. This role will manage 1 - 5 direct reports. |   | This includes, but is not limited to, the following elements: |   | - Establish, lead, maintain and improve the corporate network of business process owners (BPOs), quality system owners (QSOs) and site functional leads to ensure cross-site understanding and support of content of new EDMS (Veeva) | - Take on the role as global QMS content owner and ensure that quality deliverables are provided according to Veeva project implementation and future operational schedule | - In collaboration with regulatory ensure that the QMS content is current with and proactively incorporate upcoming regulatory guidelines to maintain, improve and innovate FDB strategy and state of compliance | - Responsible for keeping team engagement, timeline and budget while implementing the EDMS, QMS and Training modules of Veeva | - Ensure that key stakeholders across the organization (BPOs, QSOs, functional leads) are informed and consulted when appropriate to ensure the QMS content is understood and supported across the FDB organization | - Assume quality ownership for Veeva system. | Long term vision for this role is to form the foundation for FDB to be ahead of the industry as it pertains to use of digital solutions and artificial intelligence in shaping the QMS processes of the future. |   | - Ensure all needed quality processes are migrated simplified and effectively from existing QMS structure (e.g. document hierarchy, document types etc.) and systems (Master Control Trackwise, Compliance wire) to Veeva. This includes governance, timeline and budget adherence and appropriate communication to all stakeholders - 70% | - Internal audit and inspection readiness coaching and execution as needed, act as QMS expert during site inspections across the network - 10% | - Ensure participation in industry foras to keep up to date with latest trends within assigned area of responsibility 5% | - Participate in other assigned Quality tasks (e.g. conduct risk assessments, corporate audits, Generate quality assessments and reports for assigned topics, run quality foras e.g. QMRs, risk register meetings etc.) 15% | - And other job duties that may be assigned from time to time (Can include cross function collaborative and project team leadership assignment consistent with personal strategic, operational and technical leadership) - 5% |   | This role has accountability above sites pertaining toQuality Management System Content and is accountable for designing and driving the QMS strategy for Quality, in close collaboration with  and Regulatory. In this role stakeholders are on all sites and the role has interaction to a broad spectrum of customers as well in the co-design of data governance models. This role will have significant impact to the FDB strategy of transforming the industry and will be consulted as the role having the latest regulatory and business trends for QMS. Unprecedented delivery is also heavily impacted by the success of this role as accountable for the quality processes robustness and compliance.
Category
Quality
Type
Full Time
Worker Type
Permanent

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