Description

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

Responsibilities

• Partner with Operations to support the Data Integrity Risk Assessment (DIRA) initiative by summarizing risks and identifying gaps in validated data-generating systems.
• Integrate shipment manifests and EDC with Watson LIMS, leveraging custom reporting to achieve a seamless sample-receipt-to-data-delivery model.
• Author Risk Assessments and partial User Test Cases for the high-resolution Orbitrap platform to introduce metabolomic capabilities.
• Author Risk Assessments and partial User Test Cases for the Illumina NextSeq2000 platform to introduce NGS (exo-some-profiling) capabilities.
• Represent BMA for data storage and movement solutions within the AWS cloud environment to ensure data integrity for large datasets.

Required Skills

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

Key Skills

Education

Any Gradute