LabWare Specialist

biotech; California (MO); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical benefits

Sick Time benefits

Job summary

PSC Biotech is seeking a LabWare Specialist in California to configure and validate LabWare LIMS in a GMP-regulated lab. Responsibilities include configuring workflows, supporting integrations, and ensuring compliance with regulatory standards.

The ideal candidate should have over 5 years of experience with LabWare LIMS in GMP environments and a Bachelor’s degree in a relevant field. A competitive salary of $85,000 – $115,000 annually, along with medical benefits, will be offered.

Qualifications

• 5+ years of hands-on experience with LabWare LIMS in GMP/GxP environments.
• Proven experience with Computer System Validation (CSV).
• Strong troubleshooting and problem-solving skills.

Responsibilities

• Configure LabWare LIMS for various workflows.
• Support integrations between LabWare and laboratory instruments.
• Ensure compliance with GxP and regulatory requirements.

Skills

LabWare LIMS Configuration

GMP/GxP Compliance

Data Integrity

Cross-Functional Communication

Education

Bachelor’s degree in Life Sciences, Engineering, or Computer Science

Tools

Empower

LabX

Job description

Role

The LabWare Specialist is responsible for the configuration, integration, and validation of LabWare LIMS within a GMP-regulated laboratory environment. This role supports end-to-end LIMS implementation activities, translating regulatory, quality, and operational requirements into compliant system designs, executing configuration builds, integrating laboratory instruments and enterprise systems, and supporting validation deliverables.

Responsibilities

LabWare Configuration

• Configure LabWare LIMS for raw materials, commercial products, stability programs, and laboratory equipment workflows.
• Develop and maintain master data, test methods, sampling plans, and product specifications.
• Apply standardized, compliant configuration design patterns to ensure scalability, consistency, and regulatory adherence.
• Support method configuration within LabWare aligned to approved laboratory processes.

System & Instrument Integration

• Design, configure, and support integrations between LabWare LIMS and laboratory instrumentation (e.g., Empower, LabX).
• Enable data flow between LabWare and enterprise GMP systems.
• Support or develop parsing scripts/interfaces in alignment with system governance and standards.
• Troubleshoot integration issues and ensure reliable system connectivity and performance.

Validation & CSV Support

• Support Computer System Validation (CSV) activities for LabWare implementations and enhancements.
• Author and/or contribute to validation deliverables.
• Ensure full requirements-to-configuration traceability.
• Support audit readiness and ensure compliance with GxP, data integrity, and regulatory requirements.

Requirements Translation & Design

• Gather and translate regulatory, quality, and operational requirements into standardized LabWare system designs.
• Ensure configurations align with approved test methods, specifications, and laboratory procedures.
• Partner with quality, validation, IT, and laboratory teams to ensure solutions are fit for intended use.

Operational Support & Execution

• Support deployment, go‑live readiness, and steady‑state operations of LabWare systems.
• Troubleshoot configuration and workflow issues impacting laboratory operations.
• Ensure stable execution of laboratory workflows in a GMP environment.
• Provide ongoing system support and continuous improvement recommendations.

Cross‑Functional Collaboration

• Collaborate with Quality, Validation, IT, and Laboratory stakeholders throughout implementation and support phases.
• Participate in requirements workshops, system design reviews, and testing activities.
• Support project timelines and deliverables as an individual contributor.

Requirements & Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field preferred.
• 5+ years of hands‑on experience with LabWare LIMS (LabWare 8 preferred) in GMP/GxP environments.
• Strong expertise in configuration of raw materials, commercial product, stability, and laboratory workflows.
• Experience integrating LabWare with laboratory systems (e.g., Empower, LabX) and supporting data interfaces.
• Proven experience supporting Computer System Validation (CSV) and authoring validation documentation (e.g., URS, IQ/OQ/PQ, traceability).
• Solid understanding of GMP, GxP, data integrity, and validation lifecycle requirements.
• Strong troubleshooting, problem‑solving, and cross‑functional communication skills.
• Experience with LIMS upgrades, large‑scale implementations, and/or inspection readiness is preferred.
• Must be authorized to work in the U.S.

Benefits

• Salary bracket: $85,000 – $115,000 annually (California salary transparency compliance).
• W2 temporary roles include Medical and Sick Time benefits.

Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.