Software Application Support and Validation Analyst

Software Application Support and Validation Analyst

Exton, PA (Corporate)

This position will have two primary responsibilities – Software application support and software validation.

The position will include providing software administrator support for applications used in the pharmaceutical industry. This includes both analytical instrument software as well as large enterprise type applications. Responsibilities would include but not be limited to user account maintenance, electronic data archiving and resolving user problems with the software. Additionally, providing support for our IDBS Electronic Notebook will be a key part of this position. This would initially include multiple administrative maintenance tasks and would potentially lead to workflow template development and implementation. Experience with the IDBS electronic notebook would be a plus. Other key applications needing support include Sciex Analyst, Watson LIMS, MSD Discovery Workbench, and Molecular Devices SpectraMax.

The other key responsibility for this position is to assist with software validation. This would involve evaluating new software, working with the laboratory technical expert, developing user requirements and test scripts, conducting gap analysis and risk assessments as well as following standard change control procedures. Previous experience with software validation, 21 CFR Part 11 and other appropriate regulations would be a plus.

The ability to work in a team environment and to learn and evaluate new software applications are essential for this position. A candidate with previous laboratory experience or one transitioning from the laboratory to application support and validation would be considered.

This position will report into the Director of Validation and Application Support.

 

 

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