Description

You will own validation and data integrity solutions for metabolomic and genomic platforms.

This role is remote.

Responsibilities

• Partner with Operations to support the Data Integrity Risk Assessment (DIRA) initiative by summarizing risks and identifying gaps in validated systems.
• Integrate shipment manifests and EDC with Watson LIMS, leveraging custom reporting for seamless sample-receipt-to-data-delivery.
• Author Risk Assessments and User Test Cases for the Orbitrap and Illumina NextSeq2000 platforms.
• Represent the team for data storage and movement solutions within AWS to ensure data integrity for large datasets.

Required Skills

• 5–8 years of experience in a regulated (GLP/GCLP/GMP) Pharmaceutical or Biotechnology environment.
• Master’s degree in engineering or related field, or equivalent relevant experience.
• Subject Matter Expert in Watson LIMS.
• Strong understanding of Computer Systems Validation and instrument lifecycle processes.
• Proficiency in Kneat, Veeva, and ServiceNow.
• Experience with Change Control, Continuous Improvement, and Deviations.
• Experience with AWS.

Preferred Skills

• Understanding of data integrity and digital compliance principles.

Key Skills

Education

Any Gradute