The Validation Analyst is focused on software product validation activities along with contributing to the continuous improvement of software development lifecycle (SDLC) and computer system validation processes.
The Validation Analyst will utilize their knowledge of industry best practices on Agile SDLC methodologies and Validation practices, along with knowledge of applicable regulatory expectations, to help drive procedural updates and/or process improvements. The Validation Analyst will be a primary point of contact to Technology teams, and will be responsible for guiding staff to ensure compliance with procedural expectations. The Validation Analyst will be responsible for designing and delivering training to the Technology teams to reinforce SDLC and Validation procedural expectations and related best practices.
The Validation Analyst serves as an SDLC process and validation subject matter expert and is an integral point of contact to the respective product teams within the Technology Department.
Note: The Validation Analyst is not a "hands-on" software testing position.
- Conduct quality reviews of software validation packages
Create and/or update procedural documentation and supporting procedural documentation
- Create and/or update validation documentation (e.g., validation plan, validation report, validation certificate)
- Report on non-compliance issues and assist with preparing CAPA plans
- Evangelize Medidata's SDLC and CSV process expectations and applicable regulatory expectations (e.g. 21 CFR Part 11, Annex 11)
- Assist with the continuous identification and design of process improvements
- Assist with the identification and implementation of corrective and preventive actions for quality issues
- Assist with the design and delivery of training on SDLC and CSV topics
- Ability to work with a cross-functional team
- Ability to effectively communicate process expectations to the teams
- Ability to evaluate issues and resolve problems or propose resolutions
- Ability to identify risks and take appropriate measures to minimize negative outcomes
- Ability to understand and articulate technical issues
- Proficiency in the use of office productivity tools (e.g. Smartsheets, WebEx, MS Word, etc.)
- Ability to serve as a subject matter expert
Your Education & Experience:
- Bachelor's degree in Computer Science, Information Systems, or related field or the equivalent work experience in a software development, software testing, or technical writer role
- Minimum of 2 years of relevant SDLC and/or Validation work experience with at least 1 year of experience utilizing an Agile SDLC methodology
- Exposure to the Life Sciences (pharmaceutical, biotech, medical devices) industry and regulatory requirements is a plus