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)