Validation Engineer

  • location: Round Lake, IL
  • type: Contract
  • salary: $50 - $55 per hour
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job description

Validation Engineer

Contract position: Large pharmaceutical manufacturer has an immediate need in Round Lake IL for a Validation Engineer. This role is responsible for the compilation, ongoing updates and dissemination of Technology transfer packages, facilitating the deployment of Particulate Matter (PM) & Leak Elimination Program/Operations initiatives. This is a contract opportunity expected to last 1 year could be longer based on performance, possible temp to perm, possible extension. Will require travel to US plants, estimated at 30%. Apply Now!

Responsibilities for the Validation Engineer
  • Facilitates the creation of Technical Transfer standard content and presentation format
  • Compiles documents and information created by engineers into a complete technical transfer package for each initiative
  • Provides validation and documentation support and expertise as needed. (May be required to participate in on-site activities at US and PR sites)
  • Performs validation activities as needed. Validation will focus on automated test equipment which is PLC and/or PC controlled with emphasis on data integrity and CFR21 part 11 compliance
  • Performs change control activities as needed to support the completion of the transfer package.
  • Creates documents for the technical package as needed (e.g. summaries, guides, training modules, engineering reports, SOPs etc.).
Requirements for the Validation Engineer

  • BS in Engineering
  • Minimum 4 years of heavy systems and software validation experience Medical device experience is strongly preferred
  • Experienced conducting equipment and process validation work in medical device or Pharmaceutical industries.
  • Experienced in validation of PLC and PC-controlled equipment
  • Experienced in compiling system documentation and completing documentation packages through change control
  • Previous experience writing and executing protocols
  • Software skills: Word, Excel(Pivot Tables, V/H Lookups, VBA, Macros), Minitab, and SharePoint; trackwise (a plus)

    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.

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