|Title:||Computer Systems Validation Specialist|
|Job Status:||Full-time, Benefited|
Celerion, a leading international clinical research organization headquartered in Lincoln, NE is seeking a Computer Systems Validation Specialist to join our team.
This full time benefited opportunity with Celerion working on site in south Lincoln. Come join a collaborative team and make your mark with us!
This role offers an opportunity to work on a variety of projects and enhancements for both off the shelf and proprietary applications. This position is responsible for direct interaction with internal customers to determine hardware, software and system requirements in accordance with regulatory requirements.
This role will create and maintain validation documentation and testing results for GxP related software programs. Also, this person will work with IT system owners and subject matter experts to develop and implement software enhancements and to ensure compliance and federal regulations.
- Performs and oversees software project implementations and change control projects
- Coordinate cross-functional leads responsible for UAT – providing them with test schedules, test data, direction, and detailed test scripts in accordance with the Release Schedule
- Defines application requirements/problem by conferring with clients; evaluating procedures and processes
- Develops solutions by preparing and evaluating alternative workflow solutions and analyzing potential software/hardware solutions.
- Authoring of all validation deliverables including Plan, Requirements, Test Plan, Design, Protocols, Traceability Matrix, Reports and Standard Operating Procedures (SOPs).
- Works closely with all business units, technology teams, and support teams to meet IT system goals
- Performing root cause analysis and risk assessments
- Perform system administrator tasks as required
- Associates or Bachelor’s degree in IT or a health-related field OR applicable experience in a medical, clinical, pharmaceutical or analytical setting
- Knowledge of 21 CFR part 11; Electronic Records and Signatures is preferred
- Experience with MS Office software
- Excellent organizational and communication skills
- Stellar attention to detail
- Self-directed, able to prioritize and make educated decisions
- Ability to stand by and support your decisions
- Full time, Monday – Friday, normal business hours
- Ability for occasional work outside of normal hours for implementations