Computer System Validation Engineer

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).

Requirements

• 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.