RSS export of vacancies - Seulement les offres à la une : No / Pays : Europe-->Royaume-Uni / Département : Europe-->Belgique-->Flandres-->Flandre orientale

2023-29473 - Launch Support Engineer

Wed, 06 May 2026 22:05:25 Z

Category : OPERATIONS/CONSULTING
Contract : Permanent contract
Position description :
Job Title: Launch Support Engineer Location: Crewe, United Kingdom (Onsite) Responsibilities: Support is required to cover the production phases of all customer vehicles, the load rate for these is approximately 1 per month. Professional services to achieve the below deliverables. Provide progress/status reports in line with project timings Creation and maintenance of Daily build plans, respecting the high-level customer delivery plan. To Liaise and interface with all elements of the project delivery team to support the build of the Customer vehicles, these areas including, project management, Operations, Workshop, and Various Engineering departments, - (This list is not exhaustive) Build documentation into relevant Bentleys systems to provide traceability of the build process of the vehicles, inclusive of History books and Control plans Agreeing on the build process for all affected componentry with all stakeholders internally and externally Ensuring that build feasibility is agreed with respect to the above Build-related problem resolution where required when vehicles are in assembly Provide progress/status reports in line with project timings using standard client formats where applicable Experience BiW, Body Sealing, Exterior/Body Hardware and Dynamic Sealing Systems, Teamcenter PLM Build Support experience Applicable legislation and certification requirements Engineering degree or equivalent qualification

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Location : Crewe CW1

2023-26479 - QC Analyst

Mon, 28 Apr 2025 08:29:25 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview The QC Analyst is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. Major Responsibilities: Responsible for the completion of QC testing related to the manufacturing of autologous products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations. Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products. Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories. Perform peer review/approval of laboratory data. Utilize electronic systems (LIMS) for execution and documentation of testing. Create, review and approve relevant QC documents, SOP’s and WI’s. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties will be assigned, as necessary

Education: A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry. Experience: A minimum of 1-2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Capabilities, Knowledge, and skills: Experience in a Quality Control setting is preferred. Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required. Knowledge of Good Tissue Practices is required. Detailed knowledge of QC test methods and related equipment is preferred Excellent written and oral communication skill are required Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process. Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice. The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. Comfortable with speaking and interacting with inspectors. This position may require occasional travel to partner sites in NJ or PA as business demands. This position may require up to 10% domestic or international travel as business demands. Language(s): English
Location : Brugge

2023-26478 - QA Investigator

Mon, 28 Apr 2025 08:29:04 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview: The QA Investigator is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and compliant product supply. Major Responsibilities: Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues. Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints. Perform analysis on quality indicating data and identifying trends. Collaborates with functional departments to resolve issues. Manage cross-functional projects with many stakeholders. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Require minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consult with manager for decisions outside established processes. Provide guidance to other employees in the interpretation of quality issues and participate in the development of technical or scientific initiatives and activities. Routinely recognize and resolve quality issues. Seek management guidance on complex issues. Drive continuous improvement.

Education: A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required. Experience: A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Key Capabilities, Knowledge, and Skills: Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices. Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and often make critical decisions with limited information. Proficient in applying process excellence tools and methodologies. Ability to pay attention to details and follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a requirement. Ability to work with others in a team environment. Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing. Ability to identify/remediate gaps in processes or systems. Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred. Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint). Language Requirements: Dutch and technical English
Location : Ghent

2023-26480 - QC Investigation Specialist

Mon, 28 Apr 2025 08:24:39 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview The QC Investigation Specialist is an exempt level position with responsibilities for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment. Major Responsibilities: In this function you will be responsible to manage the QC related deviations and execute qualitative investigations in close collaboration with the analysts and the involved stakeholders according to the required procedures. Ensuring thorough root cause analysis is performed using the correct tools and proper CAPAs are defined in order to reduce non-conformances and deviations in the future. Different tasks are (but are not excluded to) Review/complete routine manufacturing and QC nonconformance/deviation investigations. Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise. Proactively work with stakeholders to implement effective CAPAs and to ensure the timely completion of corrective and preventive actions within the laboratories. Provide recommendations for the improvement of processes by working cross functionally with multiple stakeholders. Work closely with management to propose/execute improvements through the change management system. Drive continuous improvement. Ability to respond with a high degree of urgency to departmental and cross functional needs and requests. Reporting/Monitoring metrics on non-conformance investigations and corrective and preventive actions (CAPA). Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Comply with all training requirements to perform duties on the job.

Education: A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required and relevant years of experience within the pharmaceutical industry. Experience: A minimum of 4 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance, manufacturing compliance, clinical quality, or cell therapy. Capabilities, Knowledge, and skills: Experience in a Quality Control setting is preferred. Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required. Knowledge of Good Tissue Practices is required. Detailed knowledge of CAR-T QC test methods and related equipment is preferred. Excellent written and oral communication skill are required. Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process. Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice. The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. Comfortable with speaking and interacting with inspectors. Language(s): Dutch & English
Location : Ghent

2023-26496 - QC Manager

Mon, 28 Apr 2025 08:24:20 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview The Associate Manager/Manager, Quality Control is an exempt level position with responsibilities for managing the operation and worklflow of the quality control laboratories in support of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data, procedures and methods, supporting laboratory investigations and ownership of various QC microbiology department projects. Major Responsibilities: Ensuring adequate training (skills-based, cGMP and safety) of associates within the department. Raw material, in-process, environmental/utility, product release, and stability testing. Investigation of laboratory non-conformances (events, deviations, and invalid assays). Maintenance, calibration and qualification of laboratory instruments and equipment. Test method verification, qualification, validation and/or transfer activities in the QC laboratories. Process Performance Qualification and Continued Process Verification activities associated with QC microbiology laboratory testing. Providing expertise in troubleshooting complex laboratory issues and demonstrating strong reasoning skills in support of ongoing laboratory investigations. Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on the-job training requirements. Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs. Contribute to global strategies related to QC laboratories which align with compliance and business objectives as well as the overall corporate vision. Manage departmental budget and resources; prepare staffing plans. Make adjustments to roles and responsibilities of department to meet business needs. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties will be assigned, as necessary

Education: A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required. Experience: A minimum of 8 to 10 years relevant work experience is required. It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 1 to 4 years of leadership experience is also required. Capabilities, Knowledge, and skills: Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices. Strong interpersonal and written/oral communication skills. Proven people management and leadership experience is required. Experience working with quality systems is required. Extensive knowledge of chemical, biochemical and microbiological concepts is required. Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred. Ability to quickly process complex information and often make critical decisions with limited information. Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities. Proficient in applying process excellence tools and methodologies. The candidate must be highly organized and capable of working in a team environment with a positive attitude. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a requirement. Experience developing and setting long-term objectives. Ability to identify/remediate gaps in processes or systems Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred. Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint). This position may require up to 10% domestic or international travel as business demands Language(s): Dutch
Location : Ghent

2023-26503 - Quality Person In Plant

Mon, 28 Apr 2025 08:24:03 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview: The Quality person in plant is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. Job duties are performed within a team according to an assigned, production shift schedule. This role will work in shift regimes supporting the 7/7 days cell processing. Major Responsibilities: Serves as a Quality person in plant in support of cell therapy manufacturing. Ensures Quality Oversight in plant covering various process related activities Performs periodic Quality checks/audits related to process, documentation and process manipulations Strive to reduce non-conformances and deviations in supported areas by proactively driving compliance. Responsible for real time review of process documentation in support of process unit operations and release activities where needed. Collaborate with site personnel to provide guidance and determine resolution for manufacturing issues. Supports in accurate and timely input, investigation and review of manufacturing deviations, CAPAs, change controls and complaints. Review and approve manufacturing procedures and batch records Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Support regulatory inspections and audits by ensuring inspection readiness within facility. Perform internal housekeeping audits. Other duties will be assigned, as necessary.

Education: A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry. Experience: A minimum of 2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A minimum of 2 years of experience with quality support in clinical manufacture is preferred. Key Capabilities, Knowledge, and Skills: Aseptic processing in ISO 5 clean room and biosafety cabinets. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices. Great attention to detail and ability to follow the procedures. The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision. Good written and verbal communication skills are required. Ability to summarize and present results, and experience with team-based collaborations is a must. Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk. Must exhibit strong leadership skills and effectively develop others. Ability to collaborate well with stakeholders, customers and peers. Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Must be able to discern the criticality of issues and to communicate to management regarding complex issues. Ability to manage conflict and issues that arise with internal or external customers. Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process. Language Requirements: Dutch and technical English
Location : Ghent

2023-26499 - QC Sample Coordinator

Mon, 28 Apr 2025 08:21:19 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Role Overview The QC Sample Coordinator, is responsible for sample management. The QC Specialist is encouraged to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively. Major Responsibilities Prepares and reviews documentation independently Responsible for QC sample and retain management Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS) Prepare documents and coordinate Sample shipment (internal and external shipments) Review logbooks and/ or LIMs to align physical quantities of samples in freezers/refrigerators Periodic inspection and consolidation of retains Document and perform sample management related non-conformance investigations Document and handle corrective and preventative action records Supports internal and regulatory audits

Requirements A minimum of a Bachelor’s degree or higher A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry A degree in Biology, Biochemistry, Microbiology, Chemistry or related field Solid understanding of regulatory requirements, policies and guidelines Experience with Quality Control document reviews and regulatory inspection processes Working knowledge of Quality systems Experience in management of retain samples using electronic systems (eLIMS) Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process This position will be located in Ghent and may require up to 5% of travel This position will occasionally require to lift up to 10 kg Language Requirements: Dutch and Technical English
Location : Ghent

2023-29474 - Vehicle Electronics & Network Development Support

Thu, 02 Nov 2023 09:55:57 Z

Category : OPERATIONS/CONSULTING
Contract : Permanent contract
Position description :
Job Title: Vehicle Electronics & Network Support Location: Crewe, United Kingdom Department: Electrical Engineering Responsibilities: Working on the client Product Emergence Process to deliver to the required business expectations of the engineering department. Ensuring correct documentation and validation of the parts and functions ensuring engineering sign-off is achieved through testing and validation at differing integration Levels (BiL points)/vehicle build and development timing points which require specific validation events. Liaison within the E/E department to ensure delivery of the expected functionality. Working with group stakeholders directly and/or indirectly to understand functions/parts/systems and the client requirements. Organisation of test facilities and arrangements to test functions on vehicles. Requirements: Detailed knowledge of CAN/Ethernet communication protocol Detailed knowledge and experience of Electronic Control Unit development from concept to series parts. UDS diagnostic protocol and diagnostic understanding. Knowledge of off-board communication protocols and Automotive Network Access devices Integration of vehicle networks to determine failures with the network and/or routing Understanding or an appreciation of the vehicle connectivity unit connection to the backend/cloud systems and the communication protocols used within these systems. Experienced in the use of Vector CANoe Understands the concept of distributed functions throughout the vehicle in order to realise functionality. Understand the requirements for data logging of CAN/Ethernet networks and use of data to problem-solve network and network gateway issues. BOM data management Detailed understanding of the package environment of all vehicle platforms Change request creation to support vehicle builds

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Location : Crewe CW1

2022-22988 - Connected Car Engineer

Thu, 02 Nov 2023 09:41:57 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
The role What you will need Automotive E/E architectures for vehicle control and connected cars services. Exposure to ERA GLONASS / EU / NA / Japan telematics testing. Grey Services – cabin pre-conditioning / remote start Understanding of V2V/V2I communication, eCall, bCall, stolen vehicle tracking (SVT) and cybersecurity. Product delivery for automotive. Automotive safety and cybersecurity standards. Key global connected car eco-system suppliers. Proven supplier management. Self-motivated, and ability to work as a leader and confidently alone. Promote cross functional team working and collaboration between departments. Provide mentorship to junior staff. Conscientious and attention to quality, reliability and safety. Excellent verbal and written communication skills. Excellent personal workload management. Flexible approach to working hours. Masters or bachelor’s degree in Engineering related degree or equivalent experience What you will be doing Produce technical product specifications and cross-functional business process definitions applicable to our connected car features across all production programmes, concept demonstrations & research activities. Produce validation test specifications for all connected car features, including customer orientated road- and track-use, and services that support internal product development, manufacturing, marketing and aftersales. Produce programme gateway work products related to connected cars, including feature definitions, project risks, validation test plans, project timing and costs. Ensure the connected car eco-system is compliant with the applicable global legislation, safety requirements and the highest standards of cyber security and data privacy. Coordinate connected car supplier activities, including cloud-based infrastructure, mobile connectivity, cyber security, data services and IoT applications focused on the customer experience and internal value. Proactive contribution to connected technologies continuous improvements and internal business growth.

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Location : Crewe

2023-29472 - Functional Safety Engineer

Thu, 02 Nov 2023 09:35:23 Z

Category : OPERATIONS/CONSULTING
Contract : Permanent contract
Position description :
Hybrid Working Crewe 2/3 Days on Site Flexi-time (40hr week) Private Healthcare & Pension Functional Safety Engineer Responsibilities Development of safety-relevant vehicle functions in accordance with ISO26262:2011 Generation, usage and assessment of safety analyses, e.g. FMEA, FTA and H&R methodology Create Impact analysis using the correct template. Attend regular meetings with interal stakeholders Create and complete the HARA template for the function Perform a PreFilter and HAZOP analysis of the functions. Review HARA document with the function team. Experienced Required Development of safety-relevant vehicle functions in accordance with ISO26262:2011 Generation, usage and assessment of safety analyses, e.g. FMEA, FTA and H&R methodology Safety-relevant hardware designs and assessments Usage in the development phase of methods/measures of software tools Electronics and circuit technology of control units in the – Drivetrain, chassis and body control domains Usage requirements management using SharePoint or DOORS.

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Location : Crewe CW1

2023-28838 - Chassis Integration Engineer

Wed, 01 Nov 2023 13:25:02 Z

Category : OPERATIONS/ENGINEERING/PRODUCTION
Contract : Permanent contract
Position description :
Hybrid Working Crewe 2/3 Days on Site Flexi-time (40hr week) Private Healthcare & Pension Chassis Integration Engineer THE ROLE Scope of the role As part of the Akkodis Automotive team, you will be involved with calibration, and validation within Chassis Integration. The position will give you exposure to a variety of different components and functions implemented into our customer's vehicle program giving you an ideal foundation to further your knowledge in vehicle development. Responsibilities Responsible for Chassis electronics integration and release of SW within the group systems. Responsible for the chassis control unit and active anti-roll bar module for the SUV line. Using OEM tools such as IDEX, CPtool, ODIS to retrieve data, flash modules, and calibration routines, and uploading engineering SW for functional safety and function tests. Responsible for taking part in test trips and activities, track injecting faults with Vector Canape, and problem-solving in the workshop area with hands-on work with the vehicle. Attending meetings with the audit team to pass through SW release Component releases with presenting information to senior stakeholders for signing off Generating SW files from the System42 database to prepare for testing and presenting it the change control board for release into production. Production issue resolved immediately with control permits DFMEA reviews for functions responsible Experienced Required Knowledge of vehicle communications networks and diagnostic protocols. Knowledge and experience of the latest vehicle electronic systems. Conversant with electronic hardware and software design processes. Use of diagnostic tools such as CANoe and CANape. Demonstrated experience working for an automotive manufacturer or relevant supplier preferable. Appreciation of sensor technologies, the methods of interfacing to such components, and how Experienced in project management for electrical functions/components

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Location : Crewe CW1