Computer System Validation Engineer

TK-CHAIN LLC

Computer System Validation Engineer

Princeton, NJ
Full Time
Paid
  • Responsibilities

    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.