CSV LIMS Lead

Location: On-site (New Jersey)

Engagement Status: Contract

Key Responsibilities

• Lead end-to-end implementation and configuration of Thermo Fisher SampleManager LIMS
• Translate laboratory and shop-floor workflows into compliant digital processes
• Manage LIMS integrations with laboratory systems and instruments
• Drive CSV activities, including URS authoring and IQ/OQ/PQ execution
• Ensure compliance with GMP / GxP regulations
• Support go-live, on-site deployment, and hypercare
• Collaborate with Quality, IT, and Lab stakeholders to ensure user adoption

Requirements

Hard Skills / Technical Expertise

• Hands-on experience with Thermo Fisher SampleManager LIMS
• Strong expertise in Computer System Validation (CSV) within GMP / GxP environments
• Proven experience authoring URS and executing IQ/OQ/PQ
• Experience integrating LIMS with laboratory instruments and enterprise systems
• Solid understanding of regulated laboratory and manufacturing processes
• Experience delivering or validating enterprise-scale IT applications
• Bachelor’s degree in a STEM-related discipline (Science, Engineering, IT, or similar)

Soft Skills / Professional Competencies

• Strong stakeholder management skills, able to work across Quality, IT, and Lab Operations
• Clear and confident communication skills, both technical and non-technical
• Ability to translate complex laboratory workflows into structured system requirements
• Highly detail-oriented, quality-driven, and compliance-focused
• Proactive, hands-on approach during critical project phases and go-live
• Strong problem-solving and decision-making capabilities
• Comfortable working in fast-paced, regulated project environments

Education

• Bachelor’s Degree in STEM field