Computer System Validation Engineer

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.

· Author and execute Installation and Operational Qualification (IQ/OQ) protocols and reports for pharmaceutical manufacturing, packaging equipment and utilities equipment.

· Assist in the design and procurement of new process and utility equipment and lead installation, start-up and commissioning or qualification activities.

· Author IQ/OQ protocols for new or used equipment purchased.

· Review IQ/OQ protocols provided by equipment manufacturers to ensure compliance with site procedures.

· 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.

· 7+ 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.