Ops (Jr/Sr) Expert Facility Start-up
Il y a 3 heures
East Flanders, Flanders, Belgique
Legend Biotech US
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h3bWhat can you expect? /b /h3pTo support the operational readiness, start-up, and long-term success of our Facility Start-up, we are looking forOps (Jr/Sr) Expertwho 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. /ph3Here’swhatyou’lldo: /h3pYou will support the startup and operational readiness of our manufacturingand GMPfacility. This includes helpingestablishprocess flows, supporting cleanroom readiness, implementing 5S principles, andoptimizingthe storage of equipment and materials. You will work closely with cross-functional teams to build efficient operational processes from the ground up. /pullipYou will contribute to technology transfer activities and help prepare the facility forcommercial manufacturing. You will support the development and improvement of work instructions, SOPs, Master Batch Records (MBRs), and operational workflows related to personnel, materials, waste, andlogistics. /p /lilipOnce 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. /p /lilipYou 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. /p /lilipYou 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. /p /li /ulh3You will actively contribute to process optimization, automation initiatives, and operational excellence projects. Byobservingfloor operations and collaborating with stakeholders across the organization, you will helpidentifyopportunities to improve efficiency, workflow design, and manufacturing readiness. /h3pYou 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. /ph3bWho are we looking for? /b /h3pbEducation /b /pulliTechnical 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. /li /ulpbExperience /b /pullipExperience with isolators, media preparation, cleanrooms, or aseptic manufacturing. /p /lilipExperience working with cGMP systems such as PAS-X,eLIMS, MES, and SAP is preferred. /p /li /ulpbLanguages /b /ph3Professionalproficiencyin English, both verbal and written. /h3pProficiencyin Dutch is a nice to have /ppbStrengths /b /ppYou are a true team player but also enjoy working independently. /pullipYou have strong interpersonal skills and a healthy dose of empathy. /p /lilipYou are flexible, resilient, and able to adapt to changing business and operational priorities. /p /lilipYou have an interest in innovation, automation, and digital solutions within manufacturing operations. /p /lilipYou havea strong desireto learn and grow. /p /lilipYou bring a hands-on mindset paired with a strong focus on quality and detail. /p /li /ulh3bWhat do
we offer
you? /b /h3pA 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. /pullipA permanent contract andan 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.
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. /ph3Here’swhatyou’lldo: /h3pYou will support the startup and operational readiness of our manufacturingand GMPfacility. This includes helpingestablishprocess flows, supporting cleanroom readiness, implementing 5S principles, andoptimizingthe storage of equipment and materials. You will work closely with cross-functional teams to build efficient operational processes from the ground up. /pullipYou will contribute to technology transfer activities and help prepare the facility forcommercial manufacturing. You will support the development and improvement of work instructions, SOPs, Master Batch Records (MBRs), and operational workflows related to personnel, materials, waste, andlogistics. /p /lilipOnce 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. /p /lilipYou 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. /p /lilipYou 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. /p /li /ulh3You will actively contribute to process optimization, automation initiatives, and operational excellence projects. Byobservingfloor operations and collaborating with stakeholders across the organization, you will helpidentifyopportunities to improve efficiency, workflow design, and manufacturing readiness. /h3pYou 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. /ph3bWho are we looking for? /b /h3pbEducation /b /pulliTechnical 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. /li /ulpbExperience /b /pullipExperience with isolators, media preparation, cleanrooms, or aseptic manufacturing. /p /lilipExperience working with cGMP systems such as PAS-X,eLIMS, MES, and SAP is preferred. /p /li /ulpbLanguages /b /ph3Professionalproficiencyin English, both verbal and written. /h3pProficiencyin Dutch is a nice to have /ppbStrengths /b /ppYou are a true team player but also enjoy working independently. /pullipYou have strong interpersonal skills and a healthy dose of empathy. /p /lilipYou are flexible, resilient, and able to adapt to changing business and operational priorities. /p /lilipYou have an interest in innovation, automation, and digital solutions within manufacturing operations. /p /lilipYou havea strong desireto learn and grow. /p /lilipYou bring a hands-on mindset paired with a strong focus on quality and detail. /p /li /ulh3bWhat do
we offer
you? /b /h3pA 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. /pullipA permanent contract andan 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.