Contract position: Immediate need for a Packaging Validation Engineer at a large medical device manufacturer in Bloomington IN. Must have a BS in Engineering and 2+ years of experience. This is a contract assignment expected to last approximately 18 months.Responsibilities for the Validation Engineer
Requirements for the Validation Engineer
- Identifies and implements necessary changes to automated inspection lines (including automated inspection machines, labeling equipment, blistering equipment, cartoning machines, and serialization equipment)
- Performs validations of automated inspection machines for syringes, vials, and cartridges, including development of vision files for particle sensors and for inspection cameras
- Performs validations of automated packaging lines (including labeling equipment, blistering equipment, cartoning machines, and serialization equipment)
- Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environment
- Serves as subject matter expert (SME) on automated packaging lines and automated inspection machine validations (Eisai machines)
- Develops Validation documentation including Process Flow Diagrams, Failure Mode Effect Analysis (FMEAs), Protocols, Final Reports, etc.
- Bachelor's degree Engineering
- Minimum of 5 years' experience in validation-related activities working in a cGMP environment is required
- Work experience in Biopharmaceutical and/or highly regulated and compliance-focused industries, ideally with exposure to cold chain/temperature controlled products.
- Background in electromechanical operations required
- Experience in Machine Vision preferred (Cognex software such as Vision Pro or Insight is desirable)
- Background in validation (IQ/OQ/PQ) including study design, and the development of Protocols, Final Reports, and SOPs etc. preferred
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.