**LIMS Validation Specialist - CSV**

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.

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.

Requirements

• 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.

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.

Schedule

This is a contract position based in Bridgeton, MO, with a hybrid work arrangement (3 days remote, 2 days onsite).

Pay

The pay range for this position is $40.00 - $70.00 per hour.

Benefits

If eligible, benefits for this temporary role may include:

• Medical, dental, and vision insurance
• Critical Illness, Accident, and Hospital coverage
• 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)