Ops Expert (Jr/Sr) – Facility Start-up & GMP Readiness

Legend Biotech EU; Oost-Vlaanderen; Sur place; EUR 65 000 - 110 000; Plein temps

Avantages offerts par ce poste

ADV-days during project phase

Meal vouchers

Company laptop

Net allowance

Insurance (group & hospitalization)

End-of-year bonus

Performance bonus

Bicycle lease plan

Résumé du poste

Legend Biotech EU seeks an Ops (Jr/Sr) Expert to help build a new manufacturing capability from ground up. You will be part of the Operational Core Team, shaping facility readiness, technology transfer, and workflows for personnel, materials, waste, and logistics in a GMP setting.

You will contribute to master records, SOPs, and batch records; perform daily sterile manufacturing activities across isolator-based, Grade C cell processing, orGrade A/B aseptic operations as needed.

Qualifications

• Technical bachelor’s degree, Master’s degree, or equivalent in Science/Biotechnology/Biomedical Sciences or related field, with hands-on ops in cGMP/ATMP environments.
• Experience with isolators, cleanrooms, aseptic manufacturing.
• Experience with cGMP systems such as PAS-X, eLIMS, MES and SAP.
• Professional proficiency in English; Dutch is a plus.

Responsabilités

• Support startup and operational readiness of the GMP facility, establish process flows, support cleanroom readiness, apply 5S, optimize storage of equipment/materials.
• Contribute to technology transfer and prepare the facility for commercial manufacturing; develop SOPs, MBRs, and workflows for personnel, materials, waste, logistics.
• Perform daily manufacturing activities in a sterile cGMP environment; support isolator-based operations or Grade C/D aseptic operations as needed.
• Follow approved procedures, GMP docs, and quality systems; assist deviations, investigations, CAPAs, and change control.
• Maintain GMP production areas with cleaning, environmental monitoring, and facility activities in Grade B/C/D cleanrooms; manage materials and waste.
• Contribute to process optimization, automation, and operations excellence; identify efficiency improvements.
• Collaborate with Manufacturing, MSAT, Quality, Engineering, Site Strategy & Excellence, Warehouse, Facility, IT and other departments.

Connaissances

Team player

Interpersonal skills

Adaptability

Attention to detail

Quality focus

Formation

Bachelor’s or Master’s in Science/Biotech/Biomedical Sciences

Outils

PAS-X

eLIMS

MES

SAP

Description du poste

Legend Biotech EU seeks an Ops (Jr/Sr) Expert to help build a new manufacturing capability from ground up. You will be part of the Operational Core Team, shaping facility readiness, technology transfer, and workflows for personnel, materials, waste, and logistics in a GMP setting.

You will contribute to master records, SOPs, and batch records; perform daily sterile manufacturing activities across isolator-based, Grade C cell processing, orGrade A/B aseptic operations as needed.