10 days old

Validation Engineer

Round Lake, IL
  • Job Code
Job Opening - Validation Engineer - Round Lake, IL

Validation Engineer

job description

Contract position: Large pharmaceutical manufacturer has an immediate need in Round Lake IL for a Validation. Responsible for the compilation, ongoing updates and dissemination of Technology transfer packages, facilitating the deployment of PM&L initiatives. This is a contract opportunity expected to last 1 year could be longer based on performance, possible temp to perm. 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)



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    Validation Engineer

    Randstad Engineering
    Round Lake, IL

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    Randstad Engineering
    Round Lake, IL

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