Validation Engineer 1

Overview

Senior Validation Engineer – Bioanalytical and Molecular Assays, CASL.

Responsibilities

• Client is seeking a Senior Validation Engineer to support digital initiatives within the Bioanalytical and Molecular Assays department of CASL.
• This role will report directly to the Senior Manager of Operations and will be responsible for delivery of efficiencies to the Watson LIMS database, along with establishment of robust data integrity solutions for metabolomic and genomic platforms.
• Partner with Operations team to support Data Integrity Risk Assessment (DIRA) initiative, which will summarize potential risks and identify gaps in validated data-generating systems.
• Work toward achievement of a seamless sample-receipt-to-data-delivery model by integrating shipment manifests and EDC with Watson LIMS, and by leveraging custom reporting features of Watson LIMS.
• Introduce/coordinate metabolomic capabilities for LC-MS team by: Authoring Risk Assessment and partial User Test Cases for the high-resolution Orbitrap platform.
• Introduce/coordinate NGS (exosome-profiling) for molecular team by: Authoring Risk Assessment and partial User Test Cases for the Illumina NextSeq2000 platform.
• Represent BMA for data storage and movement solutions within client AWS cloud environment to achieve data integrity for large metabolomic and genomic datasets.

Requirements

• Master's degree in engineering or related field or relevant experience; a combination of education and experience may be considered.
• 5 - 8 years of experience working in a regulated (GLP/GCLP/GMP) Pharmaceutical/Biotechnology environment.
• Strong understanding of Computer Systems Validations and instrument lifecycle processes.
• Subject Matter Expert in Watson LIMS.
• Understanding of the principles surrounding data integrity and digital compliance.
• Proficiency in Kneat, Veeva, and ServiceNow.
• Experience with Change Control, Continuous Improvement, and Deviations.

Preferred Qualifications

• Strong communication skills (verbal and written).
• Demonstrated ability to work independently and collaboratively on cross-functional teams.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Seniority Level

Mid-Senior level

Employment Type

Contract

Job Function

Pharmaceutical Manufacturing