Randstad Validation Engineer in Round Lake, Illinois

Validation Engineer

job details:

  • location:Round Lake, IL

  • salary:$55 - $63 per hour

  • date posted:Thursday, December 20, 2018

  • experience:0 years

  • job type:Contract

  • industry:Miscellaneous Manufacturing Industries

  • reference:145457

job description

Validation Engineer

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 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. Will have travel to the plants (20-30%) US and Puerto Rico. 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)

Benefits

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.