Senior Analyst - Quality Digital & Innovation; LIMS​/MODA)

Job Description

Job Title
:
Quality Digital & Innovation, Senior Analyst (LIMS/MODA)

Location
: USA Mass Bio Ops, Massachusetts

As a Quality Digital & Innovation, Senior Analyst (LIMS/MODA), you will support the administration, maintenance, configuration, and continuous improvement of laboratory systems supporting the Massachusetts Biologics Operations (MBO) site. You will work primarily with Lab Ware LIMS and MODA, maintaining workflows and master data, supporting system and instrument integrations, and providing first-tier application support to QC laboratory personnel. The role will also support computer systems validation activities, system documentation, and change management while ensuring laboratory systems remain compliant with applicable regulations and data integrity requirements.

This position requires strong technical knowledge of Lab Ware LIMS, including experience with Lab Ware 8, as well as the ability to collaborate closely with QC, laboratory, manufacturing, IT, vendors, and global system stakeholders.

• Maintain and update workflows, master data, and configurations within Lab Ware LIMS and MODA to support routine business operations and continuous improvement.
• Assist with system and instrument integrations, including configuring interfaces between LIMS and QC laboratory instruments and coordinating with Technical System Owners and Global DD&T partners.
• Perform master data updates and resolve master data issues while supporting routine system administration activities.
• Provide first-tier application support to QC laboratory end users, including troubleshooting and resolving routine system and usage issues.
• Create and maintain method verification scripts, system documentation, and other technical documentation supporting new functionality and routine system updates.
• Support computer systems validation activities, including validation plans, user requirements, protocols, reports, and related documentation.
• Configure and maintain interfaces between laboratory systems and QC instruments, including experience with Modbus or similar communication protocols where applicable.
• Support change controls, system requests, and IT ticketing activities through systems such as Service Now while coordinating required communications and approvals.
• Partner with laboratory, QC, manufacturing, IT, vendors, and other stakeholders to identify opportunities for system and process improvements while maintaining the validated state and data integrity of laboratory systems.
• Support regulatory inspections and serve as a technical subject matter expert for applicable laboratory systems and processes.

• Bachelor's degree in Engineering, Computer Science, Business, Chemistry, Biology, or a related discipline preferred; equivalent relevant work experience may be considered in lieu of a degree.
• 2–4 years of pharmaceutical or biopharmaceutical industry experience, preferably supporting laboratory systems or QC environments.
• Strong hands‑on configuration and development experience with Lab Ware LIMS and/or MODA; experience with Lab Ware 8 is highly desirable.
• Experience with SQL or SQL‑based configuration capabilities, particularly in support of Lab Ware LIMS.
• Experience developing or configuring interfaces between LIMS and QC laboratory instruments; experience with Modbus or similar communication protocols is desirable.
• Experience supporting computer systems validation, including validation plans, URS, protocols, reports, and related documentation.
• Working knowledge of cGxP, GAMP 5, ISA‑88, 21 CFR Part 11, data integrity principles, and validated laboratory systems.
• Strong collaboration, communication, problem‑solving, and organizational skills, with the ability to…