Senior MES Engineer - CAR-T Manufacturing Excellence

Legend Biotech; Raritan (NJ); In loco; USD 127.000 - 167.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, and vision insurance

401(k) with company match

Eight weeks paid parental leave

Commuter benefits

Descrizione del lavoro

Legend Biotech in Raritan, NJ seeks a Senior MES Engineer to drive MES design, development, and deployment to support CAR-T manufacturing. The role reports to the MES Lead and collaborates with Tech Support, Process Improvement, Validation, QA, IT, and Supply Chain.

You will gather user requirements, translate them into robust EBRs, and ensure on-time delivery while maintaining compliance with cGMP and SDLC.

Competenze

• Bachelor's degree in engineering or related field required.
• 6–8 years of relevant experience in Cell/Gene Therapy cGMP manufacturing preferred.
• Experience translating business needs to system requirements.
• Experience leading MES enhancements and validation activities.
• Ability to work in a fast-paced, matrixed environment.

Mansioni

• Drive eBR development and on-time deployment in MES.
• Coordinate with departments to gather requirements and deliver robust EBR.
• Lead design testing, release planning, and demos for MES updates.
• Act as MES SME for CAR-T site initiatives.
• Coordinate MES updates with ERP and other SCM systems.
• Lead MES validation activities per SDLC (CTP, IQ/OQ).
• Develop standard documentation and SOPs.
• Support QA investigations and QMS.
• Prepare site MES readiness for FDA audits.
• Interact with all levels of the organization.
• Train Manufacturing Excellence and Operations on MES usage.

Conoscenze

Analytical thinking

Problem solving

Communication (verbal & written)

Cross-functional collaboration

Change management

Formazione

Bachelor's degree in engineering

Advanced degree preferred

Strumenti

PAS-X MES

ERP systems

IT systems interfaces

Descrizione del lavoro

Legend Biotech in Raritan, NJ seeks a Senior MES Engineer to drive MES design, development, and deployment to support CAR-T manufacturing. The role reports to the MES Lead and collaborates with Tech Support, Process Improvement, Validation, QA, IT, and Supply Chain.

You will gather user requirements, translate them into robust EBRs, and ensure on-time delivery while maintaining compliance with cGMP and SDLC.