Job Title: Lab Validation Specialist

Work Location: Wake County, North Carolina

Summary:

This position is responsible for managing the lifecycle of laboratory instrumentation and software, with a focus on ensuring data integrity and regulatory compliance. The role involves validating Chromatography Data Systems, onboarding new equipment, and maintaining compliance with industry standards.

Responsibilities:

• Lead validation activities for Chromatography Data Systems, including drafting and executing User Requirement Specifications, Validation Plans, and Summary Reports.
• Oversee the onboarding process for new laboratory instruments, coordinating with vendors and internal teams for seamless integration.
• Develop and execute Installation, Operational, and Performance Qualification protocols for analytical instruments.
• Assist with system administration tasks such as configuring user roles, managing projects, and ensuring proper data archival within laboratory software systems.
• Manage change control processes for system upgrades or hardware replacements, ensuring compliance with relevant regulations.
• Act as the Subject Matter Expert for software-related instrument issues, conducting root cause analysis for validation deviations.
• Maintain and update the Validation Master Plan and ensure all technical documentation is prepared for audits and inspections.
• Support troubleshooting efforts and provide guidance on maintaining compliance with regulatory standards.

Qualifications:

• Bachelor’s degree in Chemistry, Biology, Computer Science, or a related scientific or technical field.
• Minimum of 3 years of experience in a GMP laboratory environment, focusing on equipment qualification and software validation.
• Hands-on experience with Waters Empower 3 and/or Thermo Scientific Chromeleon 7.
• Familiarity with additional laboratory systems such as LIMS is advantageous.
• Strong understanding of GxP, GAMP 5, and Data Integrity (ALCOA+) principles.

Published Category: Quality & Validation