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    <title>Export RSS des offres - Seulement les offres à la une : Non / Région : Europe--&gt;Belgique--&gt;Flandres, Europe--&gt;Espagne--&gt;Navarra</title>
    <link>https://akka-empl.talent-soft.com/handlers/offerRss.ashx?Rss_Region=2357%2C2664&amp;lcid=1036</link>
    <description />
    <language>fr-FR</language>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=26479&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Brugge</category>
      <title>2023-26479 - QC Analyst</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
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&lt;br /&gt;&lt;br /&gt;
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&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Brugge&lt;br /&gt;
</description>
      <pubDate>Mon, 28 Apr 2025 08:29:25 Z</pubDate>
    </item>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=26478&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Ghent</category>
      <title>2023-26478 - QA Investigator</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
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.&lt;br /&gt;&lt;br /&gt;
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&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Ghent&lt;br /&gt;
</description>
      <pubDate>Mon, 28 Apr 2025 08:29:04 Z</pubDate>
    </item>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=26477&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Brugge</category>
      <title>2023-26477 - Software Test Design engineer</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
Product quality and Customer satisfaction are the main targets. Design software verification test for H&amp;F software components, through Hardware In the Loop, Virtual Verification and Digital Twin, including test cases description and human machine interface.
Guarantee no safety issues and serious malfunctions due to software bugs or lack of system integration are present at the end of validation process, in accordance with system specifications, Functional Software specification, diagnosis specification, Interlock specification and Functional Safety documentation.
Secure correct deployment of Test Environment configurations and processes.
With attention to Test Environment:secure on time availability of testware suites meant to check multiple Electronic Control Unit functionalities and their integration.
Guarantee correct Test Environment setup for HIL, VV and DTwin
Guarantee correct software issues description and collection through Data Management tool.
Design all maneuvers meant to support module SW verification AND testware development. 
 Essential responsibilities:
Develop the automatic testcase as per Test Plan from the system and vehicle specifications, defining the integration test and the validation test protocol. Automatic testcase it’s an important asset of Design Verification team.
Guarantee the execution of the test activity according to the Test Plan and sw Validation timeline for the release to production in agreement with Stakeholder.
Guarantee correctness of HIL/VV/DTwin configurations.&lt;br /&gt;&lt;br /&gt;
Qualifications/requirements:
Electric/Electronic Engineering Master’s degree or equivalent.
Basic knowledge of virtual test environment for SW validation (skill on tools as dSPACE is a plus) with passion on test automation.
Knowledge of Matlab/Simulink/State Flow
Knowledge of Python programming language.
Knowledge on Vector tools, likes CANalyzer, for CAN BUS protocol or LIN.
Knowledge of electronic tools/devices and schematics.
Knowledge of the issues relating to interfacing of sensors/actuators with electronic control units
Skills to work on more projects in parallel.
Brief experience in Automotive field.
Be curious, proactive, supportive, and willing to learn.
Preferred :
From 1 to 3 years of experience as SW Test Engineer is preferred.
Knowledge on hydraulic control devices used on agricultural systems and related control designs characteristics
Languages: English (Dutch is a plus)&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Brugge&lt;br /&gt;
</description>
      <pubDate>Mon, 28 Apr 2025 08:28:46 Z</pubDate>
    </item>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=26476&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Brugge</category>
      <title>2023-26476 - Embedded Software Designer</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
Convert system requirements into embedded vehicle software
Design the system control strategy and corresponding software architecture
Maintain, archive, and control application source code. Manage SW releases.
Implement the software architecture and strategies, requirements for closed loop control algorithms, and related software control logic in C or MATLAB/Simulink
Define &amp; Execute test scenarios to verify the implemented control / monitoring strategy.
Verify the implementation in a virtual simulation environment
Create tools/applications to test your code more efficiently and automatically
Verify the implementation on the physical vehicle
Support Product Validation Engineers as they conduct Functional and Performance testing.
Produce documentation in support of design, implementation, and test activities.&lt;br /&gt;&lt;br /&gt;
Master in Electronics/ICT or equivalent by experience
Experience in C-programming
Knowledge of MATLAB/Simulink is a plus
Affiliation with agricultural machinery and hands-on mentality
Team player with good communication skills
Knowledge on SAE J1939, CAN, UDS and ISOBUS software protocols is a plus&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Brugge&lt;br /&gt;
</description>
      <pubDate>Mon, 28 Apr 2025 08:27:57 Z</pubDate>
    </item>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=26474&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Brugge</category>
      <title>2023-26474 - Production Planning &amp; Control Process Advisor</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
Guide plants for MOP (methods of procedure) development, lead the Industrial portion of the S&amp;OP process, validate changes on the Commercial Requirements, assess impact on MFG Plants, find best possible solution to satisfy the requirements (Calendar,  Daily rate, Off line, OKTS, and Fleet management) in the MFG Operating Plan, including Component Plant impacts.  Document cost impact (down days, overtime, rebalances, HC termination, ....) Manpower consolidation after MOP cycle
Lead Industrial portion of the Sales and Operations planning (S&amp;OP) process, respecting   WW S&amp;OP timeline
Component Plant Requirements, based on Final Plant MOPs, manage constraints, solve capacity issue between final plants and component plants
Manage the "Material Overplanning" process in the plants, both Final Assy Plants as well as Component Plants, thru MRP MOPs, in order to book capacity in the supply base
Ensure Off Line / OKTS  in line with Plan, OKTD to support the Wholesale plan of Commercial, manage the Blocked Units / FAI OK on PAD delay
Ensure the Order Coherence process monitoring (working with Plant, S&amp;OP and Commercial)
Priority setting to support specific commercial priorities
Launches in line with Platform Plan (Check alignment the to product Launches plan)Team work with SharePlan Team and SupplyChain KPI team for Mop tools improvement and
process improvement&lt;br /&gt;&lt;br /&gt;
Daily interaction with Plant, Procurement and Purchasing/Commodity (plants antennas,…) to highlight potential gaps and ask for support where not possible to achieve on our own.
Weekly attendance to the L2/L3 call. Within L2, support and follow up to suppliers as requested.
Guide arbitration between plants and region.
Support to the Interplant planning process for components
Standardized Plants view of requirements data to allow to drive suppliers through arbitration. Std management document showing status / progress, allowing to take the decision to remove supplier from crisis follow-up (back to normal process)
Interaction with suppliers to delivery in line with the given promises and share new promises.
Ensure plants achieve expected delivery Performance to Spare Parts on FLT's, and maximize the performance on SLT and Urgent orders to minimize the impact for our final customers
Support to the Plant to analyze the root causes in order to eliminate/reduce the Urgent Freight
WMF NA flow providing weekly analysis of the promises of the suppliers highlighting points of attentions (missing promises, past dues, blocked orders etc.). Weekly analysis of the aging inventory at ISC.
Assure plants meet Inventory Levels targets: Manage BDG &amp; Fcst1/2/3 Inventory target planning, in coordination with Finance.&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Brugge&lt;br /&gt;
</description>
      <pubDate>Mon, 28 Apr 2025 08:27:37 Z</pubDate>
    </item>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=26472&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Brugge</category>
      <title>2023-26472 - Precision Technology Program Manager</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
In Precision Technology, we make iron smarter.  Our team members deliver innovative solutions helping our customers to be more productive, save time, lower costs, and to operate sustainably.  From vehicle displays, application controls, steering solutions, digital services and telematics, to fully autonomous driverless technology, we develop solutions that solve challenges for customers around the world.
As the Precision Technology Program Manager with Equipment Portfolio team, you will be responsible to plan, manage, and direct all product development activities, to meet customer needs and fit within the capabilities of the Precision Technology team. The Equipment Portfolio team works across component and platform programs to ensure that on time launch of products to meet the customer needs, thereby having a positive impact on the business.
Manage end to end execution of Precision Technology deliverables for major equipment programs
Manage end to end execution of Precision Technology initiatives/projects.
Work closely with internal and external teams (Product Marketing Mangers, Technical Product Managers, Engineering/Development, Architecture, Security, Product Validation, etc.) to develop and execute short-term and long-term plans, policies, procedures, resources, and initiatives.
Work with leadership team to maintain accountability to budgets, plans, and initiatives.
Gains knowledge of the customer and business needs; thereby contributing to strategic decisions.
Measure and monitor project performance. Create and review project status reports to support close surveillance over product development and support events to assure proper allocation of resources.
Ensure project plans and timelines are met by internal and external resources through Program Increment (PI) team plans and commitments.
Understand and manage the program risk throughout the life cycle.
Serve as a liaison and mentor to assist with and expedite product related issues.
Assist with contract review and meeting the requirements.
Monitor and initiate improvement projects to current processes or policies.
Holds post-program lessons learned to look for issues and opportunities for improvement.
Effectively communicate to stakeholders with the appropriate content and frequency.
Provide feedback to the PMO regarding process items that could improve the efficiency and effectiveness of the entire product development process.&lt;br /&gt;&lt;br /&gt;
Bachelor’s degree in Engineering, business, or related technical field
Minimum of 4 years of experience in software/electronic hardware; or equivalent combination of education and experience
Thorough knowledge of product development and procedures, including general finance exposure
Ability to manage a diverse range of technical operations
Experience managing budgets and increasing efficiencies
Knowledge of Agile frameworks such as Scrum, SAFe, Kaizen
PMP or Six Sigma preferred
Demonstrated leadership, organizational, documentation, analytical, and decision-making skills
Strong skills in the Microsoft Office Suite (Outlook, Excel, Project)&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Brugge&lt;br /&gt;
</description>
      <pubDate>Mon, 28 Apr 2025 08:25:00 Z</pubDate>
    </item>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=26480&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Ghent</category>
      <title>2023-26480 - QC Investigation Specialist</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
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.&lt;br /&gt;&lt;br /&gt;
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 &amp; English&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Ghent&lt;br /&gt;
</description>
      <pubDate>Mon, 28 Apr 2025 08:24:39 Z</pubDate>
    </item>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=26496&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Ghent</category>
      <title>2023-26496 - QC Manager</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
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&lt;br /&gt;&lt;br /&gt;
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&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Ghent&lt;br /&gt;
</description>
      <pubDate>Mon, 28 Apr 2025 08:24:20 Z</pubDate>
    </item>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=26503&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Ghent</category>
      <title>2023-26503 - Quality Person In Plant</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
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.&lt;br /&gt;&lt;br /&gt;
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&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Ghent&lt;br /&gt;
</description>
      <pubDate>Mon, 28 Apr 2025 08:24:03 Z</pubDate>
    </item>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=26467&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Brugge</category>
      <title>2023-26467 - Continuous Improvement Project Engineer</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
Facilitate Kaizen Events in which a cross-functional team works in a focused manner to implement their improvement ideas.
Assist the Operations team in their 'root cause problem solving' analyses (following from reporting the daily management gemba walk).
Identify and reduce process waste.&lt;br /&gt;&lt;br /&gt;
Bachelor or Master's degree in electro-mechanics with at least 2 years' experience.
Strong interpersonal and communication skills.
An intrinsic motivation to improve processes.
Capable of coaching and leading cross-functional team within a given scope.
Strong analytical skills.
Creative in problem solving.
Microsoft Office skills such as PowerPoint, Excel and Word.
Hands on mentality.
Competent to quickly learn (complex) manufacturing processes and collaborate with others to identify opportunities data driven.
Competent to teach and coach colleagues new knowledge in Continuous Improvement concepts.
An initial Maintenance / Manufacturing / Engineering / QA / QS experience is a plus
2 years' experience in similar sector.
Good knowledge of the Dutch language, both oral and written, is required.&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Brugge&lt;br /&gt;
</description>
      <pubDate>Mon, 28 Apr 2025 08:23:28 Z</pubDate>
    </item>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=26499&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Ghent</category>
      <title>2023-26499 - QC Sample Coordinator</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
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&lt;br /&gt;&lt;br /&gt;
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&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Ghent&lt;br /&gt;
</description>
      <pubDate>Mon, 28 Apr 2025 08:21:19 Z</pubDate>
    </item>
    <item>
      <link>https://akka.talent-soft.com/MyTalentsoft#/TS_MyTS/VacanciesAndAlert.aspx?target=Offers&amp;idOffre=33877&amp;idOrigine=503&amp;LCID=1036</link>
      <category>OPERATIONS/ENGINEERING/PRODUCTION</category>
      <category>CDI</category>
      <category>Pamplona</category>
      <title>2025-33877 - Técnico/a de Soporte en Calidad M/F</title>
      <description>&lt;b&gt;Métier : &lt;/b&gt;OPERATIONS/ENGINEERING/PRODUCTION&lt;br /&gt;
&lt;b&gt;Contrat : &lt;/b&gt;CDI&lt;br /&gt;
&lt;b&gt;Description du poste : &lt;/b&gt;&lt;br /&gt;
Desde Akkodis, un partner líder en ingeniería y tecnología, buscamos un/a Técnico/a de Soporte en Calidad para trabajar dentro del sector industrial con un de nuestros principales clientes referente en el sector eólico.

📍Ubicado en Pamplona.
 
El/la profesional será responsable de garantizar el correcto seguimiento y resolución de incidencias de calidad, liderar procesos clave como la obsolescencia de materiales, y actuar como punto de conexión entre almacenes, regiones y proveedores.
 
Funciones:
 
🔹 Gestión de incidencias de calidad: Identificación, análisis y resolución de problemas entre almacenes/regiones y proveedores.
🔹 No conformidades: Inicio y seguimiento del proceso de gestión de no conformidades con proveedores.
🔹 Obsolescencia de material: Liderar la implementación del proceso de discontinuidad de materiales, asegurando trazabilidad y cumplimiento.
🔹 Notificaciones técnicas: Recepción, coordinación y distribución de instrucciones técnicas para la gestión de kits de reparación en almacenes.
 
Ofrecemos:
 
✔ Contrato indefinido.
✔ Participación en proyectos estratégicos con un cliente internacional líder en su sector.
✔ Desarrollo profesional y formación continua.&lt;br /&gt;&lt;br /&gt;

Requisitos:
 
📌 Formación: Ciclo Formativo de Grado Superior (FP) o Ingeniería Técnica relacionada con calidad, logística o industrial.
📌 Experiencia: Entre 1 y 3 años en posiciones similares, preferentemente en entorno industrial o logístico.
📌 Idiomas: Inglés nivel mínimo B2
📌 Habilidades clave: Buena capacidad de análisis, orientación a resultados, comunicación efectiva y trabajo en equipo.&lt;br /&gt;
&lt;b&gt;Lieu : &lt;/b&gt;Pamplona&lt;br /&gt;
</description>
      <pubDate>Wed, 16 Apr 2025 07:54:46 Z</pubDate>
    </item>
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