CSV Engineer

Profile: Computer Systems Validation (CSV) Engineer - LIMS & Lab automation Integration

Skills: Scitara DLX, Spotfire, Statistica, and AWS Redshift.

Strong grasp of data integrity, ERES (21 CFR Part 11), .

Experience - 5+ Years

Time- 3 Hrs Per Day (Between 9 AM IST to 7 PM IST)

Location: Remote

Role Overview:

We are seeking an experienced LabVantage LIMS Integration & CSV Specialist to lead system integration, validation, and data analytics initiatives within a regulated (GxP) environment. The ideal candidate will have deep hands-on experience with LabVantage LIMS 8.7, Hamilton systems, and Scitara DLX, as well as a strong understanding of computer system validation (CSV), data integrity, and compliance standards.

Key Responsibilities:

• Lead and manage integration of LabVantage LIMS 8.7 with Hamilton systems using Scitara DLX.
• Design, implement, and maintain data pipelines leveraging AWS Redshift for data storage and analytics.
• Develop visualization and analytical solutions using Spotfire and Statistica to support business and scientific insights.
• Create, review, and maintain validation documentation including URS, FS, RTM, IQ/OQ/PQ in compliance with internal and regulatory requirements.
• Perform risk-based validation assessments to ensure adherence to GxP, data integrity, and ERES (21 CFR Part 11) guidelines.
• Support validation activities related to data integration, reporting, and dashboard development.
• Serve as CSV Subject Matter Expert (SME) during audits, inspections, and project meetings, ensuring system compliance and readiness.
• Collaborate cross-functionally with IT, QA, and laboratory teams to maintain validated systems and ensure end-to-end data integrity.

Required Skills & Experience:

• 5+ years of hands-on Computer System Validation (CSV) experience in regulated (GxP) environments.
• Proven experience with LabVantage LIMS (preferably version 8.7), Hamilton liquid handling systems, and Scitara DLX integrations.
• Working knowledge of Spotfire, Statistica, and AWS Redshift data pipelines.
• Strong understanding of data integrity principles, ERES (21 CFR Part 11), and risk-based validation approaches.
• Demonstrated ability to create and manage comprehensive validation documentation and test protocols.
• Excellent communication, documentation, and stakeholder management skills.

Job Types: Part-time, Contractual / Temporary, Freelance
Contract length: 6 months

Pay: From ₹20,000.00 per month

Expected hours: 15 per week

Benefits:

• Work from home

Experience:

• CSV: 5 years (Required)
• AWS red Shift: 3 years (Required)
• LabVantage LIMS: 3 years (Required)

Work Location: Remote