Role & responsibilities
Position: Senior LabWare LIMS Developer
Position Summary:
ProvenTech Consulting Pvt. Ltd. is seeking a Senior LabWare LIMS Developerwith deep expertise in LabWare LIMS v6, v7, v8configuration, development, and implementation within the pharmaceutical, biotech, and R&D domains. The ideal candidate will design, configure, and maintain LIMS solutions, develop automation scripts, manage instrument integrations, and support global clients in validated environments following GxP, 21 CFR Part 11, and FDA/MHRA, TGAstandards.
This is a technical leadership role, requiring strong knowledge of LIMS Basic, Crystal Reports, SQL, ELN template development, and system integrations, along with the ability to collaborate effectively with cross-functional teams and end-users.
Key Responsibilities
1. LIMS Design, Configuration & Development
- Configure and enhance LabWare LIMS v6, v7, v8applications based on client requirements.
- Develop and maintain ELN Templates, Parsing Scripts, and Automation Scriptsfor direct and file-based instruments.
- Configure Product Specifications, Analyses, Sample Login Templates, Batch Test Templates, and CoA Reports.
- Develop custom functionalities using LIMS Basic Programming, Event Triggers, Subroutines, and User Dialogs.
- Perform system configuration managementacross development, QA, and production environments.
2. Reporting & Data Management
- Design and customize Crystal Reports, Jasper Reports, and SQL-based dashboardsfor QC and R&D data visualization.
- Configure and validate Visual Workflows, Query Tags, Stored Queries, and Explorer Viewsfor data tracking and trending.
- Manage data migration, specification setup, and analysis master data configuration.
3. Instrument Integration & Automation
- Develop and maintain parsing scriptsto integrate analytical instruments (HPLC, GC, FTIR, UV, etc.) with LabWare LIMS.
- Work with cross-functional teams for instrument interfacing, data parsing, and automationusing LIMS Basic and JavaScript.
- Ensure data integrity and traceability from instrument acquisition to LIMS storage.
4. System Validation & Compliance
- Prepare validation deliverables such as URS, FS, DS, IQ, OQ, and PQ documentationas per GxP requirements.
- Participate in LabWare version upgrades (v7 v8)and validation of updated functionalities.
- Support compliance with 21 CFR Part 11, EU Annex 11, and Data Integrityprinciples (ALCOA+).
- Provide support during regulatory audits and internal quality assessments.
5. Technical Support & Leadership
- Act as a technical lead or SME (Subject Matter Expert) for LIMS implementation and enhancement projects.
- Provide L2/L3 technical supportfor troubleshooting, performance optimization, and user queries.
- Mentor junior developers, conduct code reviews, and ensure adherence to validation documentation standards.
- Collaborate with clients and cross-functional teams for solution design, demonstrations, and UAT support.
Required Skills & Technical Expertise
- Primary Skills:
- LabWare LIMS (v6, v7, v8) configuration, administration, and development
- LabWare LIMS Basic Programming
- LabWare ELN Template Design & Migration (eE to ELN)
- Automation Scripts, Subroutines, User Dialogs, Event Triggers
- Parsing Script Development for Instrument Integration
- Crystal Reports / Jasper Reports / SQL Reports
- Visual Workflows, Query Tags, and Stored Queries
- Secondary Skills:
- Oracle PL/SQL, MySQL, and SQL Server
- Java, VBA, HTML, and JavaScript scripting
- GxP, 21 CFR Part 11, Data Integrity, and Computer System Validation (CSV)
- Understanding of Laboratory Processes: Stability, Environmental Monitoring, Cleaning Verification
Qualification & Experience
- Education:
- Bachelors or master’s degree in computer science, Information Technology, or Life Sciences.
- Experience:
- 8–15 yearsof total experience with at least 5+ yearsin LabWare LIMS configuration and development.
- Hands-on experience in pharmaceutical, biotech, or life sciencesenvironments is mandatory.
- Prior exposure to validated systems (GxP, FDA, MHRA environments)preferred.
- Certifications in LabWare LIMS Administrator (Level 1/2)or LabWare ELN Analystare highly desirable.
Preferred Tools & Technologies
- LabWare LIMS v6/v7/v8
- Crystal Reports, Jasper Reports
- Oracle / SQL Server Databases
- JIRA, ServiceNow, Remedy, HP ALM
- Microsoft Office Suite, O365
- Java IDEs (Eclipse, IntelliJ), SQL Developer, TOAD
Certifications (Preferred)
- LabWare Certified Administrator – Level 1 & Level 2
- LabWare Certified ELN Analyst
- LabWare Certified LIMS Basic Developer