During phase 1 the role will be day shifts Monday – Friday. | | Once the facility 'goes live' in phase 2, the Lead Production Technologist role will be responsible for leading a team in either USP and/or DSP processing, ensuring batch activities are completed on time in a safe and compliant manner whilst supporting other members of the team with troubleshooting, training and acting as first point of call for any process deviations. | | During phase 2 the successful applicant will step onto working shifts with their designated team. | | Principal Accountabilities | 1. Demonstrate ownership and leadership within the manufacturing environment by ensuring relevant EHS and GMP standards are continually maintained. The job holder will lead by example and demonstrate the ability to challenge and change unacceptable practices to continually improve ways of working in manufacturing. | 2. Has extensive knowledge of the manufacturing process and operation of associated production equipment, acts as the primary manufacturing contact throughout the lifecycle of Technology Transfer and process execution (GMP preparation, manufacture and batch disposition). | 3. Collaborates within programme teams to create all documentation required to execute a manufacturing process, ensures processes transferred to the manufacturing facility are designed to operate safely and compliantly. | 4. Creates, monitors, executes, adjusts, and communicates manufacturing plans and co-ordinates associated production team resource to achieve manufacturing schedule targets. | 5. Provides appropriate decision making and assessment of impact on product quality through a thorough understanding of the theoretical concepts and principles relating to cGMP manufacture. | 6. Leads process related investigations in collaboration with development and engineering teams to establish the root cause of failures. |
The Principal Production Technologist role is a leadership role within the New Manufacturing Facility (Borealis). There are 2 phases to this role; in phase 1 the successful applicant will join the Borealis project team and contribute to the set up ways of working and establishment of their respective teams. In phase 2 the successful applicant will become responsible for ensuring the upkeep of a safe, compliant and audit ready manufacturing stream. | | Duties include: | - Management of manufacturing team | - Technology Transfer | - Root Cause Analysis | - Ensuring efficient organisation of activities to ensure manufacturing schedule is achievable. | - Monitor production status to ensure delivery | - Strives to improve efficiency and Quality in the preparation and execution of manufacturing processes. | - Makes recommendations on the basis of analysis and operational experience. | - Provides training or coaching to support changes/improvements or to address identified deficiencies in knowledge or capability
The Production Technologist responsibilities develop with experience ranging from New Start/Trainee to Senior Production Technologist. | | 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
- Maintain current understanding of legislation and best practice in all areas of policy. | - Advise managers and staff on the application and implications of company HR & OD policies and procedures. | - Provide general HR & OD administration support. | - Provide support to secondees and staff employed under a VISA, which may include specialist third party assistance. | - Administer and implement changes forms to reflect the HR/Payroll and LMS to reflect changes in organisation structure, job appointments, cost centres, and new positions. | - Maintain and administer the company’s LMS in a timely manner for example course set up, training attendance, trainer competence. Provision of reports on request. | - Ensure all electronic and manual filling systems are kept up to date. | - Assist with the logistics of training courses including the sourcing of providers. | - Arrange site specific training in adherence to EHS/GMP policy. | - Raise requisitions and reconciliation of invoices in SAP
- Managing all administration activities supporting expansion project recruitment | - Facilitating and coordinating assessment days | - Managing a high volume of applications | - Supporting with hard to fill vacancies with direct sourcing | - Supporting with the initial screening of CVs and assessing them for suitability against role requirements | - | Working closely with the TA Adviser to set up and manage recruitment campaigns | | - | Ensure every candidate has an efficient and effective recruitment experience | | - | Ensure recruitment documentation is completed correctly with Line Managers and HR & OD Admin Team
- Schedule, plan and maintain qualified status for GMP equipment and utilities across all manufacturing assets. | - Ensure best practice operating methods are deployed by providing system expertise. | - Ensure permanent inspection readiness for GMP equipment and utilities across all manufacturing assets. | - Deliver improvements to GMP equipment and utility systems through the execution of improvement plans, utilising knowledge of process performanceand risks | - Help resolve operational problems such as deviations/ QIPs/ CAPAs by helping to drive investigations. | - Maintain system records which effectively capture and convey corporate knowledge of site GMP equipment and utility systems. Write and issue operatingphilosophies which deliver the required availability of site services. | - Interface with internal or external technical experts and peers to maintain a broad knowledge of the technology and regulations which impact on GMPequipment and utilities.
- Graduate or Process Engineer | - Support incoming new product introductions to the MCC facility | - Purchase and qualification of new processing equipment in a GMP compliant way | - Liase with maintenance and plant to ensure equipment is in good working order and review improvements where needed to ensure that MCC Plant is operating in a safe compliant way.
The Principal IT/OT Infrastructure and Security Architect will lead the creation and maintenance of the IT/OT roadmaps, and joint strategies for the mission critical infrastructure, this will be based on global alignment with all relevant stakeholders. They with drive the cybersecurity capabilities and roadmaps globally across IT and OT and ensure alignment with established standards such as NIST 800-82, ISA/IEC62443, CIS-20, and ISO27001. The role will lead on the solution design and delivery on all FDB complex projects regarding technical and security requirements on a global scale. The role will have a high degree of influence over technology strategies, and you will be expected to navigate the organization across both IT, OT & QA globally to ensure common ground and alignment. Because of the specialized nature of the role, it will be integral in not only enterprise architecture, but also in the project estimation/delivery/management, vendor selection, outsourcing activities, transitioning to operations, and in ongoing dialogues with our key stakeholder in OT, Business, and leadership. | - Responsible for the creation, management and governance of the IT/OT architecture, strategy and 5-year roadmaps. Responsible for the governance and running of the global FDB Architectural Review Board (ARB) to ensure standards and alignment are maintained - 30% | - 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 - 35% | - 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 - 20% | - And other job duties that may be assigned from time to time | | The breadth of knowledge/skills/experience required to successfully perform the job | | - 5+ years in a Principle/ Lead Architect role in a global enterprise business, or 10+ Years in a 4th Line / Architect role | - Solid business acumen and at-ease when engaging with senior leadership | - Experience of tracking emerging issues, strategies, roadmaps, patterns, and technologies over time to assess opportunities and risks to the business | - Adept at communicating with technical and non-technical stakeholders at all levels, and across organizations, using architecture communication techniques | - Adept at gaining support from business and technical stakeholders for architectural initiatives with high levels of risk, impact and complexity | - Able to use architectural governance and assurance to make design decisions and manage technical risks at the appropriate level | - Experience of enabling the implementation of strategies or visions across the organization by advocating for resources and removing blockers | - Experience of defining strategies or visions across teams that align with organizational objectives | - In depth knowledge of how to direct the implementation of a strategy and or visions, by creating appropriate long/short term roadmaps or plans | - Good understanding of security regarding open-source technologies | - Experience of creating technical designs characterized by high risk, impact, and complexity | - Experience of representing architectural governance as part of wider governance, for example, legal or commercial
The Principal Global Laboratory Support Engineer is a member of the Infrastructure & Operations (I&O) and Global Desktop Engineering team, specializing in lab computerized instrument systems. This role is responsible for supporting IT-connected analytical lab equipment located in Quality Control (QC), Product Development (PD), VGT, as well as in manufacturing areas and warehouses. | | - Provide general IT support and platform services according to agreed service model | - Resolves and/or coordinates the resolution of hardware technical issues | - Optimise system configurations to maximise performance and ensure availability | - Perform periodic maintenance and systems review, including security roles, performance, and data integrity
As a Senior Infrastructure Engineer, you will be part of Global I&O 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 position will aid in designing, building, deploying, and maintaining the FDB IT infrastructure utilising the latest technology. The role is responsible for ensuring that IT platforms are secure, reliable, backed up and always available. In addition, the role will also provide the technical delivery of projects / solutions and provide 3rd level Infrastructure support duties as required. | | RESPONSIBILITIES AND SCOPE | | - Provide the day-to-day BAU support of the FDB Physical, Virtual and Cloud based IT Platform | - Interface with the IT/OT teams for coordination and integration of the IT infrastructure | - Ability to create, follow and implement technical roadmaps | - Deliver technical activity tasks (design, build, testing) on complex IT and Business projects | - Delivery of availability, capacity, and continuity management tasks | - Implementing security best practice | - Monitoring of the FDB platform | - Work with the established service management tool (ServiceNow) to record, update and manage incidents | - Suggest service improvements in process and technologies used by FDB to meet business objectives. | - Platform patching and vulnerability management | - All other service deliverables dependant on business needs | BEHAVIORAL SKILLS | - Excellent organizational and planning skills with the ability to manage a variety of tasks and responsibilities with a clear delivery focus. | - Thrives in a dynamic busy environment, can prioritize tasks appropriately and copes with pressure well; can accommodate numerous competing demands. | - An excellent communicator who is comfortable dealing with a variety of audiences (e.g., Executive Directors, advisers, staff, and 3rd party IT suppliers, and can tailor communications appropriately without approval. | - Flexible and adaptable to an ever-changing environment with the ability to work under pressure whilst remaining focused and calm. | - Proven experience of delivering infrastructure design and support within an enterprise environment.
| 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.