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.
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