Quality Digital & Innovation

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 LabWare 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 LabWare LIMS, including experience with LabWare 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 LabWare 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 ServiceNow 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., At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

• 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 LabWare LIMS and/or MODA; experience with LabWare 8 is highly desirable.
• Experience with SQL or SQL-based configuration capabilities, particularly in support of LabWare 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 manage multiple workstreams and work effectively with laboratory, manufacturing, IT, vendors, and global stakeholders., The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.