Sr. MES Engineer

Legend Biotech; Raritan (NJ); Sur place; USD 127 000 - 167 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401(k) with company match

Eight weeks paid parental leave

Commuter benefits

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Analytical thinking

Problem solving

Communication (verbal & written)

Cross-functional collaboration

Change management

Formation

Bachelor's degree in engineering

Advanced degree preferred

Outils

PAS-X MES

ERP systems

IT systems interfaces

Description du poste

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a Sr. MES Engineer as part of the Manufacturing & Supply team based in Raritan, NJ.

Role Overview

The Senior MES Engineer will be a driving member of the Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for independently driving and performing EBR development and administration at the Raritan site to support production processing while managing interactions with other functions including but not limited to Tech Support, Process Improvement, Validation, Supply Chain, Operations, QA, Reg CMC, and IT. This individual will be held accountable for on time delivery of electronic batch record (EBR) updates while suggesting, evaluating and implementing system improvements, drive applicable process and facility updates, and support qualification activities associated with MES (PAS-X).

Key Responsibilities

This individual will be responsible for rapidly gaining the necessary process knowledge of the product to develop EBR designs that fit the site's needs. The major responsibilities will include but are not limited to:

• Drive eBR development, modeling, and on time deployment in MES
• Accountable for coordinate with other departments to gather user requirements, gauge effort, and deliver robust, right first time EBR
• Participate in and deliver design testing, release planning, and demos with Ensure successful roll-out of MES update with minimal corrections/ revision based on end user feedback.
• Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring MES
• Lead the coordination of MES updates with other Supply Chain Systems (ERP, eLIMs, ).
• Drive, coordinate and execute right first time MES validation activities according to the Software Development Lifecycle (e.g. commissioning test Plans (CTP), Installation/Operational Qualification (IOQ).
• Responsible for defining standardization and update documentation (e.g. SOPs, Wis, Technical & Design Specifications, and Qualification Protocols) with alignment to Global Procedures.
• Act as a Site MES SME to support Quality Investigations, Corrections, and QMS
• Build the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.
• Ability to interact with all levels within the organization.

This individual is responsible for the training of Manufacturing Excellence and Operations on MES utilization and ensuring that Manufacturing Excellence and Operations properly assess updates and impact.

Requirements

• A minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• A minimum of 6-8 years of relevant experience is required. Demonstrated experience translating business needs to system requirements. Cell/Gene Therapy cGMP manufacturing and project planning experience preferred.
• Provide technical expertise of Change Control process as well as oversight of the MES team to ensure smooth implementation of system enhancement activities.
• Accurately and reliably gauge task effort and plan work to meet project timelines
• Work closely with the development and MS&T organization to ensure translation of changes from concept to implementation, building long term implementation and support plans.
• Work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Provide technical recommendation and limitations associated with MES functionality in the evaluation of potential process changes for effectiveness, value, risk, and priority.
• Drive the implementation of MES enhancements that would provide reduction in COGs, and increase throughput, capacity, and quality compliance.
• Work cross-functionally across Technical Operations and interface with IT to drive the design and implementation of new system updates for cell therapy development and manufacturing.
• When necessary, support studies related to process improvement and implementation of new manufacturing execution system technologies.
• An ability to build strong partnerships and effectively integrate with cross functional collaborators to drive projects/programs forward in a matrixed environment.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Clear and succinct verbal and written communication skills.

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays

Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay): $127,313 USD - $167,099 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.