Validation Engineer Needed by Industry Leading Medical Device Company
- Springfield, MO
- Quick Internal Growth Opportunities Available
One of the biggest molecular research institutes in the industry is look for a qualified and motivated individual looking to join the award-winning team as a Validation Engineer.
The right candidate for this position will have confidence supporting validation activities throughout the plant. This includes assisting in defining, completing, and documenting validation activities and providing technical assistance throughout production when needed.
The Validation Engineer will also play a key role in resolving quality issues, making system improvements, and participating in implementation of said improvements. They must be able to develop a thorough understanding of cGMPs and provide consultation when necessary.
The Validation Engineer will have the following responsibilities:
- Assist in cleaning, process, and equipment validation activities throughout the plant.
- Coordinate validation and cGMP-related activities.
- Conduct validation or qualification tests of new/existing processes, equipment, and/or software.
- Prepare and review validation plans, protocols and reports.
- Prepare and conduct cleaning validation studies per the internal master plan.
- Utilize data analysis techniques and software to review test results and determine main cause of defects, safety risks, and performance problems.
- Maintain validation procedures and appropriate documentation to support installation, operational, cleaning and performance testing.
- Perform training on validation issues and documentation
- Communicate cross-functionally on validation issues and requirements.
- Track all validation documentation through the plant as needed.
- Manage and complete APR section related to validation.
- Compare data / review trends - Communicate areas of concerns to management
The ideal candidate will have the following skill set:
- Bachelor's in Chemical or Mechanical Engineering
- 2+ years validation experience
- Demonstrates good interpersonal/communication skills
- Computer literate - Function ability with word processing, spreadsheets, project scheduling, and presentation software.