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Program Manager II (Airtable Integration Specialist) Epitec Staffing
Culver City, CA5 days ago
- $63.36 Per Hour
Karwell Technologies
- Thousand Oaks, CA
- 30+ days ago
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Skills
- Biotech and Pharmaceuticalunmatched
- Change Controlunmatched
- Communication Skillsunmatched
- Cross-Functionalunmatched
- Data Qualityunmatched
- Design Patterns Programming Methodologiesunmatched
- Documentationunmatched
- Environmental Communicationsunmatched
- GMP (Good Manufacturing Practices)unmatched
- Laboratory Equipmentunmatched
- Laboratory Information Management System (LIMS)unmatched
- Laboratory Operationsunmatched
- Laboratory Systemsunmatched
- Labwareunmatched
- Leadershipunmatched
- Manufacturingunmatched
- Materials Testingunmatched
- Product Testingunmatched
- Quality Assurance Methodologyunmatched
- Regulationsunmatched
- Requirements Validation/Verificationunmatched
- Scripting (Scripting Languages)unmatched
- Testingunmatched
- Time Managementunmatched
- Traceabilityunmatched
Description
Job Description:
- LabWare LIMS Configuration Specialist to support the LabWare 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 LabWare LIMS designs and ensure stable execution of configured workflows in a regulated manufacturing environment.
- Workstream Leadership & Scope Definition.
- Support a dedicated workstream supporting implementation of raw material and commercial product processes within LabWare LIMS 8.
- Define and manage LabWare build across.
- Raw materials and commercial product master data.
- Test workflows.
- Laboratory equipment and interfaces.
- Configure raw materials, commercial products including stability, and laboratory equipment in LabWare LIMS using standardized, compliant design patterns.
- Approved test methodologies.
- Product specifications.
- Sampling plans.
- Apply controlled build practices and normalized templates to ensure consistency, scalability, and compliance.
- Translate regulatory, quality, and operational requirements into standardized LabWare LIMS designs.
- Support validation activities by providing clear documentation and traceability for configured LabWare objects following Takeda internal procedures.
- Configure and support instrument interfaces between LabWare 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 LabWare 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 LabWare configurations are fit for intended use and operationally sustainable.
- Proven hands on experience configuring LabWare LIMS (LabWare 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.
- Instrument systems (e.g., Empower, LabX).
- Strong cross functional communication skills in regulated environments.
- Experience supporting LabWare upgrades or major LIMS implementations.
- Experience working in biopharmaceutical or pharmaceutical GMP environments.
- Experience supporting inspection readiness activities related to LIMS.
- Deliverables & Success Criteria.
- Completed on time LabWare LIMS configurations for raw materials, commercial products, and equipment integration.
- Clear requirements to configuration to validation traceability.
- Stable, compliant execution of configured workflows in operations.
- Successful integration between LabWare and laboratory instruments.
- This role requires close collaboration with Takeda Quality, Validation, IT, and Laboratory teams.
- Work must follow Takeda change control, validation, and data integrity requirements.
- Onsite presence may be required based on project phase and site needs.
Numbers & Facts
| Location | Thousand Oaks, CA |
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