Description
A contract manufacturer, located on the Wisconsin/Minnesota border, is in need of Validation Manager. The company services medical and commercial markets and has annual sales of $500 million. In addition, 75% of revenue is generated from drug delivery, medical device and diagnostic products.The Validation Engineer will have the following responsibilities:
- Design and maintain the validation system in line with current standards
- Oversee ongoing improvement of validation policies
- Ensure validation activities are completed to cGMP standards
- Draft and maintain Validation Master Plan for the facility, utility and equipment
- Work cross functionally with Production and Quality Control
- Lead Impact, GAMP and DQ assessments
- Oversee execution of validation for production manufacturing and cleaning processes
- Develop process validation protocols
The Validation Manager must meet the following requirements:
- B.S. or Engineering
- 7-10 years experience in performing and leading validation studies within the medical device industry
- Strong understanding of cGMP and regulatory standards
- Experience leading a team
- Stong communication skills
- Team oriented
This is a 6 month contract to hire position ($45-$50/hour), if you are interested please apply now or call Dana at .
To find out more about Real please visit www.realstaffing.com