Job Description

Key Responsibilities

LIMS / ELN Configuration & Development

  • Design, develop, and maintain LabWare LIMS and ELN templates , including tests, worksheets, calculations, and reports.
  • Configure sample lifecycles, workflows, result entry screens, and approval processes .
  • Develop and maintain ELN experiment templates , data capture forms, and standardized methods.
  • Implement calculations, validations, and business rules using LabWare LIMS tools and LIMS Basic (or equivalent scripting).

Requirements Gathering & Support

  • Collaborate with laboratory scientists, QA, and stakeholders to gather and document user requirements.
  • Translate business and regulatory requirements into functional LIMS/ELN designs.
  • Provide user support, troubleshooting, and issue resolution related to LIMS/ELN templates.

Compliance & Quality

  • Ensure configurations comply with GxP, FDA 21 CFR Part 11, ALCOA+, and data integrity principles .
  • Support system validation activities (IQ/OQ/PQ), including documentation and testing of templates.
  • Participate in audits and inspections as a LIMS/ELN subject matter expert.

Integration & Documentation

  • Support integration with laboratory instruments and external systems (e.g., CDS, ERP, MES).
  • Create and maintain technical documentation, SOPs, and user guides for LIMS/ELN templates.
  • Assist with system upgrades, enhancements, and change control activities.

Required Qualifications

  • Bachelor’s degree in Chemistry, Biology, Computer Science, or a related scientific/technical field .
  • Hands-on experience with LabWare LIMS and/or LabWare ELN configuration and template development.
  • Strong understanding of laboratory workflows (QC, R&D, stability, microbiology, etc.).
  • Experience with regulated environments (GxP) and validation practices.
  • Basic scripting or configuration experience (e.g., LIMS Basic, SQL ).

Preferred Qualifications

  • Experience with LabWare instrument interfacing and data import/export.
  • Knowledge of ELN best practices for method standardization and data reuse.
  • Prior involvement in LIMS/ELN implementation or migration projects .
  • Strong analytical, documentation, and communication skills.

Key Skills

  • LabWare LIMS
  • LabWare ELN
  • Template & workflow configuration
  • GxP & data integrity compliance
  • Requirements analysis
  • Validation & documentation

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