Azzur Group is searching for a Computer System Validation Engineer to join our growing team of consults. If meaningful work, long lasting relationships, a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you.
Essential Duties and Responsibilities
- Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes.
- Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
- Perform testing of the entire SDLC, including version/change control and new software rollouts.
- Develop releases on multiple platforms to ensure that all code released to production systems meet or exceed pre-defined quality standards.
- Utilize knowledge of all phases of Software Project Development Life Cycle and broad contribution to Analysis, Design, Development, Testing and Deployment of Software Applications.
- Ensure that the testing is sufficient to meet regulatory requirements (21 CFR Part 11, ISO 13485, ISO 14971).
- BS in Engineering, Science or equivalent technical degree.
- 5+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strong interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast paced multitasking environment.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.