LabWare LIMS 8 Configuration Specialist

Veriipro; Cambridge (MA); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

Veriipro is seeking an experienced LabWare LIMS Configuration Specialist to support the implementation, configuration, and deployment of LIMS in a GMP-regulated lab environment. The ideal candidate will configure LIMS 8 components, design laboratory workflows, manage master data, and integrate instruments with LabWare LIMS while ensuring data integrity and compliance.

Collaboration with QA, Validation, IT, and Operations is essential.

Qualifications

• Hands-on experience configuring LabWare LIMS, preferably LIMS 8.
• Experience in GMP-regulated laboratory environments.
• Familiarity with validation and CSV activities.

Responsabilités

• Configure and maintain LabWare LIMS 8 components (workflows, specifications, test templates).
• Support design and implementation of lab workflows for material/product testing.
• Interface LabWare LIMS with LabX, Empower, and other systems.
• Participate in CSV, requirements traceability, and validation documentation.
• Collaborate with QA, Validation, IT, and Operations to deploy and support the system.

Connaissances

LabWare LIMS configuration

Laboratory workflow design

CSV/validation support

Documentation and compliance

Stakeholder communication

Outils

LabX

Empower

instrument interfaces

Description du poste

We are seeking an experiencedLabWare LIMS 8 Configuration Specialist to support the implementation, configuration, and deployment of Laboratory Information Management Systems (LIMS) within a GMP-regulated pharmaceutical or biotechnology laboratory environment.

The ideal candidate will have hands-on experience with LabWare LIMS 7/8 configuration, laboratory workflow design, master data management, specifications, test templates, and laboratory system integrations.

This role will work closely with Laboratory Operations, Quality Assurance, Validation, and IT teams to translate business and laboratory requirements into compliant, scalable, and validated LIMS solutions.

Roles and Responsibilities

• Configure and maintain LabWare LIMS 8 components, including application objects, workflows, master data, specifications, test methods, and test templates.
• Support the design, configuration, and implementation of laboratory workflows for raw material testing, commercial product testing, and stability programs.
• Configure laboratory processes, sample lifecycle management, analytical testing workflows, results entry, review, and approval processes.
• Support integration of laboratory instruments, analytical equipment, and external laboratory systems with LabWare LIMS.
• Work with laboratory platforms such as LabX, Empower, and other analytical instrument or laboratory data management systems.
• Translate business, laboratory, and quality requirements into functional and technical LIMS configurations.
• Collaborate with business stakeholders and laboratory SMEs to gather requirements, assess process gaps, and recommend appropriate LIMS solutions.
• Support functional testing, system integration testing, user acceptance testing (UAT), and regression testing.
• Support computer system validation (CSV) activities, including requirements documentation, requirements traceability, test execution, defect management, and validation documentation.
• Ensure LIMS configurations align with applicable GMP requirements, data integrity principles, and organizational quality standards.
• Support configuration troubleshooting, defect resolution, system enhancements, and laboratory interface issues.
• Participate in change control, impact assessments, configuration updates, and implementation activities.
• Collaborate with Quality Assurance, Validation, IT, and laboratory operations teams to ensure successful system deployment and ongoing support.
• Maintain accurate technical and functional documentation in accordance with regulated laboratory practices.

Required Qualifications

• Hands-on experience configuring LabWare LIMS, preferably LabWare 8; experience with LabWare 7 is also acceptable.
• Experience implementing, configuring, or supporting LIMS solutions in a GMP-regulated laboratory environment.
• Strong understanding of laboratory workflows, sample management, testing processes, specifications, and results management.
• Experience supporting one or more of the following laboratory areas:
  • Raw material testing and release.
  • Commercial product testing and release.
  • Stability testing and stability study management.
  • Laboratory instrument and equipment integration.
• Experience with LIMS functional testing, system integration testing, UAT, and validation activities.
• Familiarity with laboratory systems and analytical platforms such as LabX, Waters Empower, or similar systems.
• Understanding of GMP documentation, change control, computer system validation, and data integrity requirements.
• Strong analytical, troubleshooting, documentation, and communication skills.
• Ability to work effectively with laboratory SMEs, Quality, Validation, and IT stakeholders.

Preferred Qualifications

• Experience with LabWare LIMS 8 implementations, upgrades, migrations, or deployments.
• Pharmaceutical, biotechnology, or life sciences industry experience.
• Experience configuring laboratory instrument interfaces and integrating analytical systems with LIMS.
• Knowledge of GMP regulations, GAMP 5 principles, 21 CFR Part 11, and electronic records/electronic signatures.
• Experience with LIMS configuration documentation, functional specifications, and requirements traceability matrices.
• Experience supporting laboratory digital transformation or enterprise LIMS implementation projects.