East Walpole, United States
11 months ago
This position resides within the MBDQ POBA organization and will report into the manager of Applied Statistics at the Walpole, MA site. The duration of this contract is expected to last approximately 12 months. The schedule is 40 hours per week, Monday through Friday, physically at the site from 8 to 5 each day. The primary responsibility is to support all software validation efforts regarding applications developed within the QT MBDQ organization. The ideal candidate would possess working knowledge and skills regarding SW validation, SW validation lifecycle, Siemens documentation and the Quality System, test scripts and communication skills (both oral and written).
Compensation is not to exceed $45/hr including any associated agency fees.
- Bachelors degree in computer science, programming, science or other related field or 10 yrs related experience
- Must have ability to write requirements, plans, protocols, test scripts, deviations, and reports.
- Capable of developing, executing and interpreting the test case scripts.
- Participate in FMEA, Risk analysis, and change impact assessments.
- Ability to develop flow-charts in Visio
- Excellent oral and written skills for cross-site and cross-function collaboration
- Dependable, motivated, focused and detail orientated
- Ability to take direction as needed and work independently on project when necessary
- Capable of managing time effectively and adhering to timelines and project schedule
- Understanding of coding and technical writing guidelines
- Understanding of SW Development Lifecycle and structured development
- Knowledge of cGMP, FDAs CFR Title 21 part 820, Part 11 compliance, and Annex II requirements as they pertain to SW validation Capable of preparing clear/concise analytical summaries and presentations
- Knowledge of SAP
- Ability to use Microsoft Office tools: Word, Excel, PPT, etc.
- Ability to apply the least burdensome approach to SW validation - timely and efficient execution of validation effort
- Experience with IQ, OQ and PQ validation efforts.