Ops (Jr/Sr) Expert Facility Start-up

legendcareerseu; Oost-Vlaanderen; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

ADV-days (project phase)

Meal vouchers

Company laptop

Insurance

Year-end bonus

Bike lease plan

Résumé du poste

Legend Biotech is seeking an Ops (Jr/Sr) Expert to help build a new manufacturing capability from the ground up in Belgium. You will join the Operational Core Team, contributing to facility readiness, technology transfer, and a smooth transition to commercial manufacturing with cross-functional collaboration.

You will work in a sterile cGMP environment, support isolator-based operations or Grade C cell processing, and maintain compliance with SOPs, batch records, and QA systems.

Qualifications

• Technical bachelor's degree or higher in science/biotech with hands-on cGMP/ATMP exposure.
• Experience with isolators, media preparation, cleanrooms or aseptic manufacturing.
• Professional proficiency in English; Dutch is a plus.

Responsabilités

• Support startup and readiness of the manufacturing and GMP facility, establishing process flows and cleanroom readiness.
• Contribute to technology transfer and prepare work instructions, SOPs, MBRs and workflows for personnel, materials, waste, and logistics.
• Perform daily manufacturing activities in a sterile cGMP environment and support isolator-based operations or Grade C/D aseptic manufacturing as needed.
• Follow SOPs, batch records and quality systems to ensure product quality, patient safety and regulatory compliance, including deviations and CAPAs.
• Maintain GMP production areas and manage materials, consumables and waste per procedures.
• Contribute to process optimization, automation, and operational excellence initiatives across the organization.

Connaissances

Team player

Interpersonal skills

Empathy

Flexibility

Adaptability

Innovation mindset

Formation

Technical bachelor's degree or Master’s in Science/Biotech

Outils

PAS-X

eLIMS

MES

SAP

Description du poste

What can you expect?

To support the operational readiness, start-up, and long-term success of our Facility Start-up, we are looking for Ops (Jr/Sr) Expert who are excited to help build a new manufacturing capability from the ground up. In this role, you will be part of the Operational Core Team and contribute to facility readiness, technology transfer activities and the successful transition towards commercial manufacturing operations. As the facility start-up progresses towards clinical and commercial readiness, you will contribute to the creation and improvement of work instructions, SOPs, and practical workflows for personnel, materials, waste, and logistics management across the manufacturing areas.

Here's what you'll do:

• You will support the startup and operational readiness of our manufacturing and GMP facility. This includes helping establish process flows, supporting cleanroom readiness, implementing 5S principles, and optimizing the storage of equipment and materials. You will work closely with cross-functional teams to build efficient operational processes from the ground up.
• You will contribute to technology transfer activities and help prepare the facility for commercial manufacturing. You will support the development and improvement of work instructions, SOPs, Master Batch Records (MBRs), and operational workflows related to personnel, materials, waste, and logistics.
• Once commercial readiness is achieved, you will perform daily manufacturing activities within a sterile cGMP environment. Depending on operational needs and your experience, you will support isolator-based operations, Grade C cell processing activities, or Grade A/B aseptic operations involved in manufacturing advanced cell therapies.
• You will follow approved procedures, SOPs, batch records, and quality systems to ensure product quality, patient safety, and regulatory compliance. You will accurately complete GMP documentation and support quality activities such as deviations, investigations, CAPAs, and change controls when needed.
• You will maintain GMP production areas by performing equipment cleaning, environmental monitoring, and facility-related activities in Grade B, C, and D cleanroom environments. You will also manage materials, consumables, and waste according to approved procedures.
• You will actively contribute to process optimization, automation initiatives, and operational excellence projects. By observing floor operations and collaborating with stakeholders across the organization, you will help identify opportunities to improve efficiency, workflow design, and manufacturing readiness.
• You will work closely with Manufacturing, MSAT, Quality, Engineering, Site Strategy & Excellence, Warehouse, Facility, IT, and other departments to ensure smooth operations and successful execution of manufacturing activities.

Who are we looking for?

Education

• Technical bachelor's degree, Master's degree, or equivalent education/experience in Science, Biotechnology, Biomedical Sciences, or a related field, potentially with prior experience of hands‑on operations in a cGMP or ATMP environment within the biotech or biopharma industry.

Experience

• Experience with isolators, media preparation, cleanrooms, or aseptic manufacturing.
• Experience working with cGMP systems such as PAS-X, eLIMS, MES, and SAP is preferred.

Languages

• Professional proficiency in English, both verbal and written.
• Proficiency in Dutch is a nice to have

Strengths

• You are a true team player but also enjoy working independently.
• You have strong interpersonal skills and a healthy dose of empathy.
• You are flexible, resilient, and able to adapt to changing business and operational priorities.
• You have an interest in innovation, automation, and digital solutions within manufacturing operations.
• You have a strong desire to learn and grow.
• You bring a hands‑on mindset paired with a strong focus on quality and detail.

What do we offer you?

A meaningful job where you will be making the difference by implementing a new phase in Legends' history. During the project phase (foreseen till +/- mid 2028), you will work 40h/week from Monday till Friday in a flex regime. As soon as the project phase ends, you will work in the existing shift regime, meaning 4 days of work and 4 days off (average working time 35 hours). Please be prepared to work across various shifts in the range starting from 6AM and ending by 2AM.

A permanent contract and an attractive salary package complemented by many fringe benefits, such as ADV-days (during project phase) and extra-legal holidays (once in shifts), meal vouchers, company laptop, net allowance, group and hospitalization insurance, double vacation pay, an end‑of‑year bonus, performance bonus and the possibility to participate in our bicycle lease plan.

• ADV-days (during project phase)
• extra-legal holidays (once in shifts)
• meal vouchers
• company laptop
• net allowance
• group and hospitalization insurance
• double vacation pay
• an end‑of‑year bonus
• performance bonus
• the possibility to participate in our bicycle lease plan

Many fun and informal events.

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a di