Validation Analyst/Lab Benchtop Systems

Introduction:

This position involves providing support for QC computerized Lab Benchtop Systems and Enterprise Instrumentation Systems. The Validation Analyst will work on system validations, compliance enhancements, maintenance updates, and version upgrades. They will collaborate with various teams to deploy digital lab system solutions and ensure GMP compliance in system design and maintenance.

Responsibilities:

• QC computerized Lab Benchtop Systems and Enterprise Instrumentation Systems, including optimizations and compliance enhancements.
• Translate system/equipment/data integration requirements from different teams to deploy appropriate digital lab solutions.
• Drive system validation activities with various partners to implement new systems and perform system life cycle upgrades.
• Author/update and approve lifecycle documents like URS, FRS, test scripts, etc., and execute them following cGxP.
• Provide support to QC labs for Benchtop and Enterprise computer systems.
• Assist with troubleshooting incidents and implement resolutions.
• Generate Periodic Reviews, system audit trail reviews, and user access reviews for systems.
• Maintain inspection readiness by adhering to internal quality policies.
• On-site presence required with possible travel between regional sites.
• Perform any additional duties as assigned.

Requirements:

Basic Qualifications:

• A bachelor’s degree in STEM or relevant academic discipline.
• Minimum 4 years of experience in a controlled cGxP environment.
• Experience authoring and reviewing computer system validation lifecycle documents.
• Experience with Document Management, QMS, and System Administration activities.
• Experience writing change controls and deviations/CAPAs utilizing GxP workflows.

Preferred Qualifications:

• Experience with Benchtop lab computerized systems like TOC, Bioanalyzers, etc.
• Experience with Enterprise Instrumentation Systems such as Chromeleon Chromatography Data System.
• Experience in life sciences, pharma/biotech, or high-tech industries.
• Experience in a regulated environment and working in a matrixed organization.
• Demonstrated ability to work independently and collaboratively in cross-functional teams.
• Strong communication skills (verbal and written).
• Experience working with laboratory instrumentation connectivity and data.
• Familiarity with Computer Systems Validation standards and deliverables.