Engineer III leads the implementation of projects to enhance and improve quality processes at ImClone by utilizing current automated quality systems platformsn (TrackWise). Works with cross-functional groups in the design and build out of TrackWise systems. Authors and executes validation plans, protocols and reports for new or upgraded systems. Provides day to day maintenance and support of existing systems.
- Work with cross-functional groups in the technical design and system configuration of new or upgraded Quality Systems that will be used to support commercial and clinical operations.
- Work with cross-functional groups to examine process/procedural issues and make recommendations to Quality Systems Management on potential solutions for implementation.
- Participate as a Quality Systems technical liaison to cross-functional committees to help ensure integration within various Quality Systems is feasible.
- Develop and execute validation plans, protocols and associated documentation related to project work.
- Provide end user support, report generation, and other duties as assigned by area manager.
- Bachelor of Science degree in a computer related field. Work experience will be considered in lieu of BS. Two years work experience for each year in study will be considered.
- Minimum of 6 years pharma/biotech experience within an IT or Automated Quality Systems role performing the design and configuration of TrackWise.
- Intermediate to advanced knowledge of general computing principles.
- Intermediate to advanced knowledge of GxP regulations (specifically, 21CFR11).
- Intermediate knowledge of system architecture (Servers, pc, networking).
- Ability to work independently as well as within a cross-functional project team.
- Self starter and self motivated is a must.
- Knowledge of at least one programming language and associated programming methodologies (SDLC) is preferred.