LIMS Validation Specialist - CSV

Job Description

We are seeking an experienced Computer System Validation (CSV) Consultant to support the implementation and qualification of a LabVantage LIMS platform within a GMP-regulated laboratory environment. The successful candidate will play a critical role in authoring, executing, and driving approval of validation deliverables while collaborating closely with Quality Control, Validation, IT, and the global France-based LIMS project team. This is a highly visible position requiring strong technical writing, project coordination, and stakeholder management skills.

Responsibilities

• Lead the development, execution, and completion of CSV deliverables associated with the LabVantage LIMS implementation.
• Author and execute validation protocols, qualification documents, and summary reports in accordance with approved validation plans.
• Coordinate protocol execution activities with Quality Control personnel and ensure timely completion of documentation packages.
• Drive document review, approval, and resolution of comments to maintain project timelines.
• Collaborate with local SMEs and global project stakeholders to ensure successful implementation and validation activities.
• Support Data Migration Protocol execution and reporting based on approved Data Migration Plans.
• Conduct Operational Qualification (OQ) activities for Certificates of Analysis (CoA) and label generation and verification.
• Qualify printers and laboratory-connected devices.
• Perform end-to-end qualification activities confirming proper data transfer between LIMS, ERP, and interfaced systems.
• Conduct Performance Qualification (PQ) activities.
• Generate Validation Summary Reports (VSRs).
• Develop Performance Monitoring Protocol and Report.

Essential Skills

• 5 years of Computer System Validation (CSV) experience.
• 3 years supporting LIMS systems in regulated environments.
• Experience writing and executing validation protocols, IQ/OQ/PQ documents, and validation reports.
• Experience with data migration qualification documentation and Validation Summary Reports (VSRs).
• Experience supporting GMP-regulated laboratory systems.
• Strong technical writing and documentation skills.
• Experience working directly with laboratory, Quality Control, Validation, and IT stakeholders.
• Excellent verbal and written communication skills.

Additional Skills & Qualifications

• Previous LabVantage validation experience is strongly preferred but not required.
• Experience with LIMS implementation, upgrades, or migration projects.
• Familiarity with laboratory workflows and Quality Control operations.
• Knowledge of GAMP 5, FDA 21 CFR Part 11, Data Integrity, and computerized system validation principles.
• Experience supporting global project teams and cross-functional stakeholders.

Work Environment

The position offers a hybrid work schedule with onboarding and training onsite as well as key team meetings or executing protocols. Technical writing can be done at home, following a probable 3-day remote and 2-day onsite schedule, which may need to flex with project needs. Core working hours are flexible with a standard from 9:00 AM to 3:00 PM, though early meetings with French counterparts may be required.

This is a Contract position based out of Bridgeton, MO.

The pay range for this position is $40.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Bridgeton,MO.

This position is anticipated to close on Aug 13, 2026.

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