Beschreibung
CSV Technical Writer
will be in charge of gathering the technical data to be send to the USI team in India to help them write the CSV documentations. we are looking for a technical writer to support a 3D Printer Project. The printer line will be primarily used for R&D purposes, but requires some SDLC deliverables to satisfy regulatory requirements.
For the role:
- Assuring that the Computerized Systems are tested and validated to satisfy regulations and addressing business and compliance needs
- Work with CSI professional to generate design documentation - functional specification and design specification
- Identify gaps in current design documentation and support the state of the installed control system
- Three plus (3+) years of experience in an FDA regulated environment with strong knowledge of regulatory compliance pertaining to software validation in IT Infrastructure and Enterprise Systems supporting business, manufacturing, or quality management (eg, Agile, SAP, MES) plus in-house developed software applications.
- Three plus (3+) years' experience within a dedicated a CSV or product software validation role. Proficient in system and software validation engineering processes, software risk management, software V&V methodologies, and software configuration management.