Technical Lead Clean Room

il y a 1 semaine


Gent, Flandre, Belgique MindCapture Temps plein

TECHNICAL LEAD CLEAN ROOM

  • Biotech
  • GhentABOUT THE COMPANY


The Technical Lead for Clean Room Operations will play a critical role in ensuring seamless daily production tasks within Manufacturing Operations.

This role involves building strong partnerships across various departments, including Quality Control, Quality Assurance, Facilities & Engineering, Manufacturing Science & Technology (MS&T), Training, Planning, and the Warehouse.

The Technical Lead will serve as the first point of contact for technicians and experts on the production floor, addressing production issues and working as part of a cross-functional team.


Key Responsibilities:

Quality Assurance Leadership:

  • Coordinate, manage, and control all quality aspects related to production activities and batch production in cGMP areas.
  • Timely review of production documentation (procedures, work instructions, logbooks, transfer forms).
  • Act as a backup for the Operations Supervisor in reviewing executed batch records (both paper and MES).
  • Conduct routine and spotcheck inspections on production documentation.
  • Manage productionrelated QMS documentation (deviations, CAPA, SOPs, cleaning validation, protocols, and reports) in collaboration with MS&T and Quality.
  • Review cGMP documents generated by Production before QA review.
  • Support communication of KPIs related to quality aspects in Production.
  • Act as the production SME for internal and external audits in collaboration with QA, escalating productionrelated matters to ensure timely decisions and followup.

Production Process Expertise:

  • Provide guidance and perform production tasks in alignment with safety policies, quality systems, and cGMP requirements.
  • Support Tech Transfer plans for new production introductions or process optimisations, including risk assessment, execution, and readiness for clinical and commercial phases.
  • Participate in developing manufacturing processes and continuous improvement initiatives within cell therapy Technical Operations.
  • Assist in the qualification/validation of new materials, consumables, and equipment.
  • Support drug product investigations, including batch failures.
  • Participate in training sessions for various manufacturing processes.
  • Communicate KPIs related to production output.

Operational Management:

  • Attend and lead (in absence of the Ops Supervisor) daily startofshift and wrapup production meetings.
  • Assign daily production tasks and ensure their successful completion.
  • Organize training sessions in collaboration with the Training team and Operations Supervisor.
  • Collaborate with the Operations Supervisor and Manager to oversee the development of production personnel and provide performance feedback.
  • Support quality and EHS risk assessments for production activities, zones, equipment, materials, and data.
  • Assist in the design, specification, construction, qualification, validation, and regulatory approval of production capabilities.
  • Identify issues and drive continuous improvement initiatives for production operations.
  • Manage inventory and ensure material availability in production zones.
  • Monitor production areas in collaboration with Maintenance/Engineering, QC, and Facility teams.
  • Ensure safe and compliant manufacturing operations per EHS and cGMP procedures.
  • Work collaboratively and flexibly within the team.
REQUIRED COMPETENCES & SKILLS

Education:

  • Bachelor's or Master's degree in Science, Bio-Engineering, Pharmacy, or related field, or equivalent experience.

Experience:

  • Minimum 2 years in operations within a cGMP or ATMP environment in biotech/pharma.
  • At least 2 years of aseptic/grade C GMP manufacturing experience.
  • At least 1 year of team or project leadership experience.

Capabilities, Knowledge, and Skills:

  • Indepth knowledge of cGMP regulations and EMEA guidance for cellbased products and cleanroom behaviors.
  • Strong leadership and communication skills to effectively influence and guide team members.
  • Ability to work independently, prioritize, and manage multiple tasks in a fastpaced environment.
  • Strong organizational skills and ability to manage shifting priorities.
  • Excellent analytical, problemsolving, and critical thinking skills.
  • Proactive, handson approach with a cando attitude.
  • Tenacity to resolve issues and deliver results.
  • Enthusiastic team player with a flexible mindset.
  • Clear verbal and written communication skills with attention to detail.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
  • Experience with MES/EBR is a plus.
  • Ability to work shifts, including evenings and weekends, and accommodate unplanned overtime.

Requirements:

  • Shift work: Early, Late, and frequent weekends. More details will be provided during the initial contact.

Languages:

  • English/Dutch

  • Room attendant

    il y a 1 semaine


    Gent, Flandre, Belgique Residence Inn, Ghent Temps plein

    Who are we?Just a few kilometres from the historic city centre lies the Residence Inn – a chic extended stay hotel, boasting 105 self-catering apartments. Opened in 2020, Belgium's first Residence Inn has quickly rose to become a leader in the local market.Aimbridge Hospitality EMEA is a division of the global Aimbridge Hospitality brand. We manage over...

  • Room Attendant

    il y a 3 semaines


    Gent, Flandre, Belgique Holiday Inn Express and Suites - Ghent Temps plein

    Who are we?The newly built Holiday In Express & Suites will be opening it's doors in October 2024, expanding our footprint and solidifying our presence in the local market.Aimbridge Hospitality EMEA is a division of the global Aimbridge Hospitality brand. We manage over 1,600 hotels and resorts worldwide that include big brands such as Hilton, Accor,...

  • Room Attendant

    il y a 1 semaine


    Gent, Flandre, Belgique Residence Inn, Ghent Temps plein

    Job Ref:INT20754Branch:Residence Inn, GhentLocation:Residence Inn, GhentSalary/Benefits:Industry leading package, including daily meal vouchers and a premium DKV hospitalization insuranceContract type:PermanentHours:Full TimeHours per week:38Posted date:03/06/2024Closing date:05/07/2024Who are we?Just a few kilometres from the historic city centre lies the...

  • Room Attendant

    il y a 1 semaine


    Gent, Flandre, Belgique Residence Inn, Ghent Temps plein

    Job Ref:INT17800Branch:Residence Inn, GhentLocation:Residence Inn, GhentSalary/Benefits:Industry leading package, including hospitalisation insurance and meal vouchers (8 euro/day)Contract type:PermanentHours:Full TimeHours per week:38Posted date:22/06/2023Closing date:24/07/2023Who are we?Aimbridge Hospitality EMEA is a division of the global Aimbridge...

  • Technical Manager

    il y a 1 semaine


    Gent, Flandre, Belgique ISS Facility Services Temps plein

    Intro:Are you searching for a challenging managerial position in a technical setting? Do you have a keen interest in leading a team and possess broad knowledge across various technical areas such as HVAC, High Voltage, and Sanitary? Our client, located in an industrial automotive environment in Ghent, is on the lookout for a skilled Technical Manager who can...

  • Workshop Technician

    il y a 1 semaine


    Gent, Flandre, Belgique Nilfisk Temps plein

    In our Workshop in Ghent we have a small, enthusiastic team of around 10 people, who are customizing small to medium sized machines for our customers. During that process quality papers are filled in to ensure that our products meets customers expectations.In this job the most important tasks are:Installing accessories on our most advanced machines (1....


  • Gent, Flandre, Belgique Go4Jobs Temps plein

    Wat wij van jou verwachten:Jouw taken:One of the most beautiful hotels in Ghent is looking for motivated chambermaids/men.They will need you to clean the rooms, change the linens and refill the bath products.You'll work one out of two weekends. After a full weekend, you always get a day off. Sometimes you'll only work one day in the weekend. It's a variable...

  • Rooms Division Manager

    il y a 1 semaine


    Gent, Flandre, Belgique Marriott Ghent Temps plein

    Job Ref:INT16861Branch:Marriott GhentLocation:Marriott Ghent, BelgiumSalary/Benefits:Industry leading salary with benefits, group insurance and hospitalisation insurance and meal vouchers (8 euro/day)Contract type:PermanentHours:Full TimeHours per week:38Posted date:17/03/2023Closing date:19/04/2023Who are we?The Ghent Marriott is managed by Aimbridge...

  • Data Engineering Lead

    il y a 1 semaine


    Gent, Flandre, Belgique TVH Temps plein

    Your role and responsibilitiesTVH is seeking a Data Engineering Lead to join our team in Waregem, BE. As a Chapter Lead, you will be responsible for leading a team of BI Data Engineers and you are ensuring the timely delivery of high-quality data solutions. You will be reporting to the Global BI & Analytics Manager.1. Leadership and Team Management: Lead and...

  • Technical Project Leader

    il y a 1 semaine


    Gent, Flandre, Belgique SAM Recruitment Temps plein

    Wat ga je doen?The tasks involve assisting in the calculation and preparation of quotations, participating in meetings and making decisions regarding price requests, contacting subcontractors and requesting quotations from suppliers, ensuring work preparation and supervision during the execution phase, both administratively and technically, and creating...

  • Technical Support Manager

    il y a 1 semaine


    Gent, Flandre, Belgique Legend Biotech EU Temps plein

    Company InformationLegend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.Role OverviewThe Technical Support Manager will...


  • Gent, Flandre, Belgique Bricsys Temps plein

    As a Java Team Lead, together with your team, you will be working on the back-end of our internal commercial IT platform.Initiatives and new ideas are important and opportunities for growth present themselves on a regular basis. Given time and personal interest, differentiating into other functions could be possible.Key tasks include Interpret functional...


  • Gent, Flandre, Belgique Clean Carp Temps plein

    **Composil in enkele woorden**Composil is leader in tapijtreiniging in België, Frankrijk en Luxemburg. Dankzij onze expertise van meer dan 30 jaar bieden wij aan onze klanten een hoge kwaliteit van dienstverlening. Waarom sluit u zich niet aan bij onze 70 medewerkers die al bij ons werken?FunctieomschrijvingAls technieker bij Clean Carp voor de regio Gent...

  • Java Team Lead

    il y a 1 semaine


    Gent, Flandre, Belgique Bricsys Temps plein

    _Bricsys , part of Hexagon, is the global technology company that creates the Bricsys 24/7 project collaboration [cloud] platform and the BricsCAD family of computer aided design (CAD) [desktop] products._ Bricsys 24/7 ensures that the right information is in the right hands at the right time to reduce risk and improve project productivity throughout the...


  • Gent, Flandre, Belgique Robert Walters Temps plein

    A global leader active in the Facility Services industry is currently looking for a Technical Facilities Director to be based in Ghent region at their client's site. As Technical Facilities Director you will directly report to the Business Unit Director.In this role, some of your responsibilities will include:Holding full responsibility over the P&L...

  • Team Lead Data Science

    il y a 1 semaine


    Gent, Flandre, Belgique BioLizard Temps plein

    Team LeadData ScienceWhowe areBioLizard is an innovative leader in the field of bioinformatics, data analytics and AI, renowned for itscommitment to excellence, focus on collaboration, and forward-thinking ethos.We are looking for a teamlead data science who embodies our values and can lead a team of Lizards in further growth. Typically, alizard adjusts to...


  • Gent, Flandre, Belgique Itineris Temps plein

    Function:The Technical Solutions Architect is the technical lead of the project from concept to delivery & acceptance, with focus on interfacing and infrastructure. The TSA maps current client architecture with future (UMAX & Azure) architecture, develops and documents the current and future technical architectures, challenges the feasibility of the...

  • DevOps Team Lead

    il y a 1 semaine


    Gent, Flandre, Belgique OTA Insight Temps plein

    OTA Insight is a commercial platform for the hospitality industry (our clients are Airbnb property owners, individual hotels and major chains like Hilton, Accor, etc.).These are exciting times at OTA Insight: we recently raised another round of funding ($80 million) and we have welcomed two new companies, Transparent and Kriya, to our organisation that will...

  • Tech Lead

    il y a 1 semaine


    Gent, Flandre, Belgique TrustBuilder Corporation Temps plein

    Overview:TrustBuilder is a European-based cybersecurity software vendor with a global reach. We are in the business of fortifying digital landscapes with our identity-centric solutions, enabling businesses worldwide to operate securely and efficiently.Our SaaS platform stands out in the industry, powered by a passwordless and deviceless Multifactor...

  • Java Team Lead

    il y a 1 semaine


    Gent, Flandre, Belgique Bricsys Temps plein

    Key tasks include Interpret functional specifications and combine these with the technical architecture Guarantee the quality of the delivered code by conducting regular code reviews, providing feedback to the Developers and proposing and following up improvements. Ensure the use of the right technologies and methodology Report back to management on the...