About USDM
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
***This role is on-site, 5 days a week in the Los Angeles Area****
*** No 3rd Party Firms***
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.
Primary Responsibilities
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
LabWare LIMS Configuration
- Configure raw materials, commercial products including stability, and laboratory equipment in LabWare LIMS using standardized, compliant design patterns.
- Ensure LabWare 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 LabWare LIMS designs.
- Support validation activities by providing clear documentation and traceability for configured LabWare objects.
Instrument & System Integration
- 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 client standards and governance.
- Support connectivity and data flow between LabWare and other GMP systems, such as LabX
Operational Readiness & Execution
- 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.
Additional Responsibilities
- Performs other related duties and assignments as required
Qualifications
- 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.
- Experience integrating LabWare with:
- 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
Education & Certifications
Bachelor’s degree in Computer Science or Information Systems or related field.
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Master’s Degree preferred
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Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
- Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
- Operate other office productivity machinery, such as a calculator, scanner, or printer.
- Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Compensation
Salary/Hourly Rate Range (W2): USD 60.00 - 75.00
The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.
Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.
All employees are eligible for USDM's rewards and recognition program.
