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Software Validation Engineer - Full-time / Part-time
| Hours | Full-time, Part-time |
|---|---|
| Location | Kenosha, WI Kenosha, Wisconsin |
About this job
Aerotek's client has a corporate mandate to go back through 18-20 products and update validation protocols for those products.
In this role, you will focus on the software portion of the validation protocols. This project is expected to last 6-9 months with the potential to go longer.
This is an excellent opportunity for someone who is experienced in writing software validation protocols to get their foot in the door with a fast growing medical device manufacturer.
On day 1, you will be responsible for:
- Reviewing current process for software validation and some examples of executed protocols. This will provide the background information and also provide the starting point for the activities to be conducted during the project.
- Work on the remaining software validations executed and documented according to the procedure.
Typical Daily Duties:
1.) Writing protocols.
2.) Working with various team members and training them on the activities contained within the protocols.
3.) Overall management and complete execution of the software validations.
Required Qualificaitons:
1.) Experience validating software used in the production process of medical devices
2.) Familiarity with FDA CFR 820, part 11 etc.
3.) Familiarity with GAMP5 (Good automated manaufacturing practices).
About Aerotek:
Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .
Aerotek is acting as an Employment Agency in relation to this vacancy.