Katalyst CRO ยท 3 months ago
Validation Engineer 1
Norwood, MA
Contract
Onsite
Senior Level
5+ years expKatalyst Healthcares & Life Sciences is seeking a Senior Validation Engineer to support digital initiatives within their Bioanalytical and Molecular Assays department. The role focuses on enhancing efficiencies in the Watson LIMS database and ensuring robust data integrity solutions for metabolomic and genomic platforms.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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