Overview
We are seeking a LIMS Specialist to join our GMP-regulated laboratory environment. The ideal candidate will manage day-to-day LIMS operations, lead and execute GMP validation and computerized system validation (CSV) activities, support system configuration and integration, and perform hands-on development where required. Strong French and English communication skills and adherence to regulated quality standards are essential.
Responsibilities
1. Administer and maintain the Labware LIMS platform to ensure reliable, secure, and compliant operation in a GMP environment.
2. Plan, execute and document GMP validation/CSV activities for LIMS changes, upgrades and integrations.
3. Develop, review and maintain SOPs, work instructions and validation documentation related to LIMS operation and change control.
4. Provide day-to-day operational support: access roles, troubleshooting, incident management and routine maintenance.
5. Lead or support system integration projects (e.g., instruments, WMS, ELN, SAP) including requirements gathering, design, testing and deployment.
6. Perform LIMS configuration, scripting and customization within Labware framework; develop and maintain custom modules, reports, queries and interfaces when necessary.
7. Implement and support data integrity controls and best practices aligned with ALCOA+ principles.
8. Train and support end users and prepare training materials.
9. Participate in change control, CAPA and audit responses; support internal and external regulatory inspections.
10. Liaise with IT, QA, laboratory management and vendors to ensure effective cross-functional collaboration.
Qualifications
11. CFC or Bachelor's degree in Life Sciences, Computer Science, Information Systems or related field.
12. Experience in GMP validation and CSV for laboratory computerized systems (IQ/OQ/PQ, validation protocols, traceability).
13. Practical programming/scripting skills (e.g., Labware scripting, SQL, .NET, Python, or similar) for customization, report development and data integration.
14. Understanding of laboratory workflows, sample lifecycle and data integrity principles.
15. Familiar with integration technologies and protocols (e.g., REST/API, HL7, OPC, FTP, database interfacing).
16. Excellent verbal and written French and English communication skills; able to produce