Senior LIMS/MODA Analyst - Quality Digital Systems

Takeda; Lexington (MA); On-site; USD 90,000 - 141,000; Full time

Job summary

Takeda is seeking a Quality Digital & Innovation, Senior Analyst (LIMS/MODA) in Massachusetts to maintain and improve LabWare LIMS and MODA systems. You will manage workflows, master data, and interfaces with QC instruments, while ensuring data integrity and regulatory compliance.

You will support validation activities, documentation, and change controls, collaborating with QC, IT, vendors, and global stakeholders to drive continuous improvement at the MBO site.

Qualifications

• Bachelor's degree or equivalent work experience in a relevant field.
• 2–4 years of pharmaceutical/biopharmaceutical lab systems experience.
• Hands-on configuration and development with LabWare LIMS and/or MODA; LabWare 8 is highly desirable.
• Experience with SQL or SQL-based configuration for LabWare LIMS.
• Experience configuring interfaces between LIMS and QC instruments; Modbus knowledge desirable.
• Experience supporting computer systems validation, URS, protocols, reports, and related documentation.
• Working knowledge of cGxP, GAMP 5, ISA‑88, 21 CFR 11, data integrity, and validated laboratory systems.
• Strong collaboration, communication, problem-solving, and organizational skills.

Responsibilities

• Maintain workflows, master data, and configurations in LabWare LIMS and MODA to support operations.
• Assist with system and instrument integrations and interface configurations between LIMS and QC instruments.
• Perform master data updates and routine system administration tasks.
• Provide first-tier application support to QC laboratory end users.
• Create and maintain method verification scripts and system documentation.
• Support computer systems validation activities and related documentation.
• Configure and maintain interfaces between laboratory systems and QC instruments, including Modbus where applicable.
• Support change controls and IT ticketing via ServiceNow and coordinate communications.
• Collaborate with stakeholders to identify system/process improvements while maintaining data integrity.
• Support regulatory inspections as a subject-matter expert.

Skills

Collaboration

Communication

Problem-solving

Regulatory awareness

Documentation

Education

Bachelor's degree in engineering, computer science, chemistry, biology, or related field

Tools

LabWare LIMS

MODA

Modbus

Job description

Takeda is seeking a Quality Digital & Innovation, Senior Analyst (LIMS/MODA) in Massachusetts to maintain and improve LabWare LIMS and MODA systems. You will manage workflows, master data, and interfaces with QC instruments, while ensuring data integrity and regulatory compliance.

You will support validation activities, documentation, and change controls, collaborating with QC, IT, vendors, and global stakeholders to drive continuous improvement at the MBO site.