LIMS Integration & Validation Engineer

Job Description

Job Description

At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a LIMS Integration & Validation Engineer.

Position Type:

• Contract
• Onsite

Required:

• Strong experience in GxP validation within regulated environments (pharma/biotech preferred)
• Hands-on expertise across the full validation lifecycle (URS, IQ/OQ/PQ, traceability, documentation)
• Experience with LIMS platforms (preferably LabWare LIMS) and system integration initiatives
• Familiarity with analytical laboratory workflows, including data generation, processing, and review
• Experience with instrument integration (e.g., CDS systems like Empower, chromatography instruments, and lab equipment such as balances/pH meters)
• Knowledge of data integrity principles and regulatory requirements (e.g., ALCOA+)
• Ability to work across technical and business teams to support digital transformation initiatives
• Strong problem-solving skills with the ability to operate in partially defined, evolving environments.

Responsibilities:

• Support LIMS transition and digital lab transformation initiatives, ensuring alignment with business and regulatory objectives
• Lead and execute end-to-end GxP validation activities, including URS, IQ, OQ, PQ, and supporting documentation
• Drive instrument-to-LIMS integration efforts across ~40 lab systems, including complex platforms (e.g., CDS) and standalone instruments
• Collaborate with cross-functional teams to define and implement data flow, data mapping, and system interfaces
• Ensure data integrity (DI) compliance and adherence to regulatory standards throughout system implementation and validation
• Analyze current manual lab workflows and support transition to fully digital, automated processes within LIMS
• Provide support for system lifecycle management, including testing, issue resolution, and documentation updates