Job Description:
Our client is looking for a Lab Informatics / Technical Analyst with demonstrated expertise in Lab Automation with intent to increase integration and ongoing support of range of automated platforms and workflows to allow fluid data acquisition and analysis. The project will involve analyzing and data gathering for implementation of 21 CFR Part 11, while supporting production automation processes from an international standpoint to ensure alignment with related global teams.
Functions will also consist of (but not limited to):
Facilitating end-users with application-based issues and field software inquiries while defining roles and tiers of access, tracking capacity and throughput, providing software installation & updates, and architect storage for applications based on company SOP’s and data retention guidelines
Assist with project specifications, drawings, workflows, methods, SOP’s, validation protocols, production automation and lab systems
Work cross-functionally with appropriate departments to support production and lab automation functions which may involve UPLCs’, GC’s, HMI’s, HPLC’s and other related hardware/software for lab systems
Provide administrative support as needed for lab hardware/software computerized systems
Plan and assist with system optimization & growth; research new applications and new technologies; work with engineers in the planning/developmental stage for production-related equipment
Required skills:
At least 5+ years of relevant job scope experience in an FDA-regulated industry
Proficiency in Virtualized Systems, programming, and source code version control systems
Lab automation, Laboratory Information Management Systems (LIMS)
AWS, Azure DevOps
Documentation generation of the following: URS, Functional Specifications, Design Specifications, Configuration Specification Document, SOP’s, and other related documentation
Excellent communication, cross-functionally collaborations, and hands-on expertise
High-throughput sequencing data analysis and method development
Plus/Nice to have:
LabX
Python, Java, C++, etc.
CA: Lab Informatics Analyst (232747)
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