Randstad Validation Engineer in Round Lake, Illinois
location:Round Lake, IL
salary:$55 - $63 per hour
date posted:Thursday, December 20, 2018
industry:Miscellaneous Manufacturing Industries
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)
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.