Technical Lead Clean Room
il y a 4 semaines
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 spot-check inspections on production documentation.
- Manage production-related 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 production-related matters to ensure timely decisions and follow-up.
**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 start-of-shift and wrap-up 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**:
- In-depth knowledge of cGMP regulations and EMEA guidance for cell-based 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 fast-paced environment.
- Strong organizational skills and ability to manage shifting priorities.
- Excellent analytical, problem-solving, and critical thinking skills.
- Proactive, hands-on approach with a can-do 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
-
Technical Lead Clean Room
il y a 1 semaine
Gent, Flandre, Belgique MindCapture Temps pleinTECHNICAL LEAD CLEAN ROOM Biotech GhentABOUT THE COMPANYThe 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,...
-
Car-t Operations Support Lead
il y a 2 semaines
Gent, Belgique Legend Biotech EU Temps plein**Company Information** Legend 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 OVERVIEW** The CAR-T Operations...
-
Room Attendant
il y a 3 semaines
Gent, Belgique Residence Inn, Ghent Temps plein**Job Ref**:INT20754 **Branch**:Residence Inn, Ghent **Location**:Residence Inn, Ghent **Salary/Benefits**:Industry leading package, including daily meal vouchers and a premium DKV hospitalization insurance **Contract type**:Permanent **Hours**:Full Time **Hours per week**:38 **Posted date**:03/06/2024 **Closing date**:05/07/2024 Who are we? Just a...
-
Room attendant
il y a 1 semaine
Gent, Flandre, Belgique Residence Inn, Ghent Temps pleinWho 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 jours
Gent, Belgique Residence Inn, Ghent Temps plein**Job Ref**:INT20185 **Branch**:Residence Inn, Ghent **Location**:Residence Inn, Ghent **Salary/Benefits**:Industry leading package including meal vouchers and ecocheques and hospitalisation insurance. **Contract type**:Permanent **Hours**:Full Time **Hours per week**:38 **Posted date**:28/03/2024 **Closing date**:30/04/2024 Who are we? Aimbridge...
-
Room Attendant
il y a 3 semaines
Gent, Flandre, Belgique Holiday Inn Express and Suites - Ghent Temps pleinWho 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 pleinJob 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 pleinJob 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...
-
Expert Cleaner 07u
Il y a 2 mois
Gent, Belgique YES!talents Temps plein**Omschrijving**: Voor deze splinternieuwe site in Gent zijn wij op zoek naar toffe cleaners ! Het betreft een pharma bedrijf waar je zal instaan voor het schoonmaken en reinigen van clean rooms, muren, vloeren, plafond, deuren, armaturen, meubilair **YT19** **Sector**: Andere sectoren **Domein**: Schoonmaak **Aanbod**: - Steeds op tijd betaalde loon -...
-
Xpert Cleaner Zwijnaarde Weekendshift Dag
Il y a 2 mois
Gent, Belgique YES!talents Temps plein**Omschrijving**: Op zoek naar een bijverdienste of een deeltijdse job ? Solliciteer vandaag voor Expert cleaner bij onze gerespecteerde klant in Zwijnaarde ! Het betreft een pharma bedrijf waar je zal instaan voor het schoonmaken en **reinigen van clean rooms, muren, vloeren, plafond, deuren, armaturen,** meubilair en roosters. Dit zijn kritische ruimtes...
-
Xpert Cleaner Zwijnaarde Weekendshift Nacht
Il y a 2 mois
Gent, Belgique YES!talents Temps plein**Omschrijving**: Op zoek naar een bijverdienste of een deeltijdse job ? Solliciteer vandaag voor Expert cleaner bij onze gerespecteerde klant in Zwijnaarde ! Het betreft een pharma bedrijf waar je zal instaan voor het schoonmaken en **reinigen van clean rooms, muren, vloeren, plafond, deuren, armaturen,** meubilair en roosters. Dit zijn kritische ruimtes...
-
Xpert Cleaner Zwijnaarde Dagdienst
Il y a 2 mois
Gent, Belgique YES!talents Temps plein**Omschrijving**: Toe aan een nieuwe uitdaging ? Solliciteer vandaag voor Expert cleaner bij onze gerespecteerde klant in Zwijnaarde ! Het betreft een pharma bedrijf waar je zal instaan voor het schoonmaken en **reinigen van clean rooms, muren, vloeren, plafond, deuren, armaturen,** meubilair en roosters. Dit zijn kritische ruimtes en is het **goed lezen en...
-
Desinfectie Labo Cleaner Zwijnaarde 16u
il y a 2 semaines
Gent, Belgique YES!talents Temps plein**Omschrijving**: Toe aan een nieuwe uitdaging ? Solliciteer vandaag voor Labo cleaner bij onze gerespecteerde klant in Zwijnaarde ! Het betreft een pharma bedrijf waar je zal instaan voor het schoonmaken en **reinigen van clean rooms, muren, vloeren, plafond, deuren, armaturen,** meubilair en roosters. Dit zijn kritische ruimtes en is het **goed lezen en...
-
Carpet and Chair Cleaning Technician
il y a 2 semaines
Gent, Belgique Clean Carp Temps plein_Composil in a nutshell_ Composil is a leading carpet cleaning company in Belgium, France and Luxembourg. Thanks to our expertise of more than 30 years, we offer our customers a high quality of service. Why not join our 70 employees already working with us? - Description of the function_ As a technician at Composil for the Ghent region, you will treat and...
-
Technical Lead .NET internationaal Bedrijf
il y a 2 semaines
Gent, Belgique Seesharp Temps plein**Technical Lead|.NET| |Internationaal bedrijf |Gent** **Tech stack**:.NET platform, C#, SQL server, Azure SQL, MongoDB, Docker, REST, HTML5, **Taal**:Nederlands **Ervaring**: 3+ **Technical Lead.NET Developer Client Details**: Dit vooraanstaande **internationale** IT-bedrijf, met een sterke focus op **intelligente bedrijfsoplossingen en...
-
Chambermaid/man - Room Cleaning Lady/man with
il y a 3 semaines
Gent, 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...
-
Technical Manager
il y a 1 semaine
Gent, Flandre, Belgique ISS Facility Services Temps pleinIntro: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 3 semaines
Gent, Belgique Nilfisk Temps pleinIn 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....
-
Lab Support
il y a 2 semaines
Gent, Belgique Page Personnel Temps pleinAdded 19/04/2024 - As a Lab Support Operator you are responsible for the maintenance of the lab. - You work in a system of 4 days work, 4 days free. **About Our Client**: To continue to conduct this extremely important research, they are looking for new motivated Lab Support Operators for the Zwijnaarde branch. - You are responsible for the daily...
-
Workshop Technician
il y a 1 semaine
Gent, Flandre, Belgique Nilfisk Temps pleinIn 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....
