17 jobs voor process engineer biotech gevonden

.Lead and supervise various units within the process, such as component preparation, production support activities, process, filling & finishing, and cryopreservation..

Lead and supervise various units within the process, such as component preparation, production support activities, process, filling & finishing, and cryopreservation..Build strong collaborative relationships with various departments, including Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Procurement & Supply Chain/Warehouse..

You will also help apply and support corrective and preventive actions (CAPAs).Main contact for regulatory agencies: You will act as the primary contact for regulatory agencies during inspections, defending investigation strategies and reports.Drive continuous improvement: You will maintain and lead the research dashboard, support QEM systems, and implement process improvements based on lessons learned.Build strong partnerships: You will build strong relationships with various stakeholders to ensure that investigations run smoothly.

Li.MS, MES, and SAP.Bedrijfsprofiel:Join our innovative biotechnology company, where we develop and commercialize life saving cell therapies.

Component preparation manufacturing, manufacturing support operations, process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to c.GMP requirements..

Component preparation manufacturing, manufacturing support operations, process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to c.GMP requirements..

Onze klant, een biotech bedrijf, gevestigd in Zwijnaarde, is een wereldwijd biotechnologiebedrijf dat de innovatieve CAR T celtheraptie naar Gent brengt.Het bedrijf maakt hiermee dagdagelijks het verschil in het leven van vele patiënten die lijden aan kanker en andere levensbedreigende ziektes..

Planning van operators voor verschillende stappen binnen het CAR T proces..Tijdig uurroosters opmaken.

Perform peer review/approval of laboratory data..Utilize electronic systems (LIMS) for execution and documentation of testing..

.Establish key stakeholder relationships with internal stakeholders (Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Planning).

Perform peer review/approval of laboratory data..Utilize electronic systems (LIMS) for execution and documentation of testing..

Lead daily shift meetings, assign tasks, and collaborate for personnel development..Ensure safe and compliant manufacturing operations within a team environment..

GMP compliance..Build partnerships with cross functional teams, addressing production issues..

You will lead and perform multiple units within the CAR T process operations (i.e.component preparation manufacturing, manufacturing support operations, CAR T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to requirements.

GMP cleanroom.You will oversee various units within process operations, including component preparation, manufacturing support, fill & finish, and cryopreservation, ensuring compliance with c.

GMP cleanroom.You will oversee various units within process operations, including component preparation, manufacturing support, fill & finish, and cryopreservation, ensuring compliance with c.

• Coordinate, manage and control all quality aspects related to support production activities:
  • Documentation (incl.Procedures, logbooks, enz.)
  • Back-up for the Operations supervisor
  • Inspection on documentation and GMP housekeeping in the support production zones
• Control QMS documentation (in line with c.GMP) in collaboration with MS&T and Quality:
  • Deviations/events, and CAPA
  • Support communication concerning KPI’s related to quality aspects in Production
• 2nd point of contact representing Supporting Production quality matters in internal & external audits
• Support optimisations of current processes within the support production areas
• Provides support to writing and revising SOPs and associated documents
• Works daily in a cleanroom manufacturing environment.
• Controls and maintains the environment (equipment & facility cleaning and environmental monitoring) of the GMP production areas
• Manage packing, sealing and sterilisation of materials and documents
• Manage timely transfer of apheresis material, raw materials, consumables to the applicable clean room and manage timely final product transfer
• Manage inventory counts, preparation of internal order
• Be present at the daily start of shift operations meetings and the daily wrap up production meetings
• Act as a SPOC to the logistics warehouse for the material availability in the supporting production areas.
• Manage inventory in the WIP and storage of cleaning agents.
• Communicates clearly with the Supervisor and Operations Technical Clean Room Lead to highlight on clean room status/material transfer status or any items related to safety, quality and efficiency