GMP Facility Start-Up Operations Specialist

Legend Biotech US; Oost-Vlaanderen; Sur place; EUR 65 000 - 95 000; Plein temps

Avantages offerts par ce poste

ADV-days during project phase

Extra-legal holidays during shifts

Meal vouchers

Company laptop

Net allowance

Group and hospitalization insurance

Double vacation pay

End-of-year bonus

Performance bonus

Bicycle lease plan

Résumé du poste

Legend Biotech Belgium seeks an Ops (Jr/Sr) Expert to help build a new manufacturing capability from the ground up. You will contribute to facility readiness, technology transfer, and transitions toward commercial manufacturing in a cGMP environment.

This role involves creating and improving work instructions, SOPs, MBRs, and workflows, collaborating with Manufacturing, MSAT, Quality, Engineering, and Site Strategy to ensure compliance and operational excellence.

Qualifications

• Technical bachelor’s degree, Master’s degree, or equivalent education/experience in Science/Biotechnology or related field.
• Experience with isolators, cleanrooms, aseptic manufacturing.
• Experience with cGMP systems such as PAS-X, eLIMS, MES, and SAP preferred.

Responsabilités

• Support startup and operational readiness of manufacturing and GMP facility, establishing process flows and storage of equipment and materials.
• Contribute to technology transfer activities and prepare SOPs, MBRs, and workflows for personnel, materials, waste, and logistics.
• Perform daily manufacturing activities in a sterile, cGMP environment and support deviations, investigations, CAPAs, and change controls.
• Maintain GMP production areas, perform equipment cleaning, environmental monitoring, and waste management in cleanroom environments.

Connaissances

Isolators & aseptic

Cleanrooms

cGMP systems (PAS-X, eLIMS, MES, SAP)

Formation

Bachelor’s degree in Science/Biotech

Outils

PAS-X

eLIMS

MES

SAP

Description du poste

Legend Biotech Belgium seeks an Ops (Jr/Sr) Expert to help build a new manufacturing capability from the ground up. You will contribute to facility readiness, technology transfer, and transitions toward commercial manufacturing in a cGMP environment.

This role involves creating and improving work instructions, SOPs, MBRs, and workflows, collaborating with Manufacturing, MSAT, Quality, Engineering, and Site Strategy to ensure compliance and operational excellence.