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Lab Systems Administrator- MODA
Job in
Lexington, Middlesex County, Massachusetts, 02173, USA
Listed on 2026-06-13
Listing for:
Sunrise Systems, Inc.
Full Time
position Listed on 2026-06-13
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist / Manager
Job Description & How to Apply Below
- Lab Ware LIMS Configuration Specialist to support the Lab Ware 8 upgrade for a US‐based GMP laboratory site. This role will lead a dedicated workstream focused on implementing raw material and commercial product workflows
, completing master data configuration
, and finalizing integration with laboratory equipment and enterprise GMP systems
. - The successful candidate will translate regulatory, quality, and operational requirements into standardized, compliant Lab Ware LIMS designs and ensure stable execution of configured workflows in a regulated manufacturing environment.
Support a dedicated workstream supporting implementation of raw material and commercial product processes within Lab Ware LIMS 8.
- Define and manage Lab Ware build across:
- Raw materials and commercial product master data
- Laboratory equipment and interfaces
Configure raw materials, commercial products including stability, and laboratory equipment in Lab Ware LIMS using standardized, compliant design patterns
.
Ensure Lab Ware configuration aligns with:
- Approved test methodologies
- Product specifications
- Sampling plans
Apply controlled build practices and normalized templates to ensure consistency, scalability, and compliance.
Requirements Traceability & Validation Support- Translate regulatory, quality, and operational requirements into standardized Lab Ware LIMS designs.
- Support validation activities by providing clear documentation and traceability for configured Lab Ware objects following Takeda internal procedures.
- Configure and support instrument interfaces between Lab Ware 8 and a variety of laboratory systems.
- May develop or support parsing scripts
, where required and permitted by Takeda standards and governance. - Support connectivity and data flow between Lab Ware and other GMP systems
, such as LabX
- Support stable execution of raw material and equipment workflows in live operations.
- Troubleshoot configuration and integration issues impacting laboratory execution.
- Partner with site teams to ensure Lab Ware configurations are fit for intended use and operationally sustainable.
- Proven hands‑on experience configuring Lab Ware LIMS (Lab Ware 8 strongly preferred).
- Strong experience with Labware within GMP laboratory operations
, particularly: - Raw materials testing
- Commercial product testing
- Laboratory equipment workflows
- Demonstrated ability to translate regulatory and quality requirements into compliant LIMS configurations.
- Experience supporting LIMS validation with full requirements traceability.
- Experience integrating Lab Ware with:
- Instrument systems (e.g., Empower, LabX)
- Strong cross‑functional communication skills in regulated environments.
- Experience supporting Lab Ware upgrades or major LIMS implementations
. - Experience working in biopharmaceutical or pharmaceutical GMP environments
. - Experience supporting inspection readiness activities related to LIMS.
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