CSV Engineer With LIMS

ob Title: CSV Engineer
Location: Vermont (On-site)
Industry: Pharmaceutical
Contract Duration: Long-term Contract

Job Summary:
We are hiring a Computer System Validation (CSV) Engineer with 5 years of experience, specializing in LIMS and digital system integrations. This role will serve as the technical bridge between the Laboratory Information Management System (LIMS) and the Manufacturing Execution System (MES), * focusing on ensuring data integrity, compliance, and alignment between systems.

Key Responsibilities:
Lead CSV activities for LIMS with a strong emphasis on data integrity and system interface alignment.

Coordinate with both lab and manufacturing teams to support LIMS MES integration activities.

Develop and maintain validation documentation including requirements, functional specs, configuration details, and test scripts.

Collaborate with IT, QA, and system owners to evaluate, document, and implement system changes and upgrades.

Ensure electronic records and signatures meet 21 CFR Part 11 and GAMP 5 standards.

Troubleshoot and support LIMS workflows, user roles, and configuration changes.

Support data mapping, migration, and system interface testing to ensure functional compatibility across platforms.

Work with vendor and internal teams on periodic review, audit readiness, and data lifecycle management.

Required Qualifications:
5 years of experience in Computer System Validation (CSV) in the pharmaceutical or biotech industry.

Proven hands-on experience with LIMS platforms (e.g., LabWare, LabVantage) and a solid understanding of their functionality and data workflows.

Familiarity with MES systems and how they interface with LIMS environments.

Strong understanding of 21 CFR Part 11, Annex 11, GAMP 5, and data integrity expectations.

Strong documentation and communication skills with experience working in cross-functional teams.

Bachelor s degree in Computer Science, Life Sciences, Engineering, or related field.

Preferred Qualifications:
Experience with interface validation, system mapping, and supporting audits or regulatory inspections related to digital systems.

Exposure to change management and technical configuration within LIMS platforms.