Validation Engineer

Description

This role is responsible for the compilation, ongoing updates and dissemination of Technology transfer packages, facilitating the deployment of PM&L initiatives.Responsibilities 1. Facilitates the creation of Technical Transfer standard content and presentation format. 2. Compiles documents and information created by engineers into a complete technical transfer package for each initiative. 3. Provides validation and documentation support and expertise as needed. (May be required to participate in onsite activities at US and PR sites). 4. 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. 5. Performs change control activities as needed to support the completion of the transfer package. 6. Creates documents for the technical package as needed (e.g. summaries, guides, training modules, engineering reports, SOPs etc.). 7. Seeks clarity from subject matter experts and translates into clear outputQualifications 1. Experienced conducting equipment and process validation work in medical device or Pharmaceutical industries. 2. Experienced in validation of PLC and PCcontrolled equipment. 3. Understanding of data integrity regulatory requirements, Electronic records and electronic signatures. 4. Experienced in compiling system documentation and completing documentation packages through change control. 5. Experienced in writing engineering or scientific reports. 6. Able to work under time pressure, take initiative and propose effective solutions to problems as they arise. 7. Able to work onlocation as needed. 8. Team player, willing to engage and support the team in order to get to the finish line. 9. Desired familiar with Baxters system and productsEducation/Experience Bachelors of Science degree in Scientific or Engineering or similar field Minimum 4 years of heavy systems and software validation experience Medical device experience is strongly preferred Demonstrated success in delivering results on several technical challenges Allen Bradley Control experience, strongly preferred Software skills Word, Excel(Pivot Tables, V/H Lookups, VBA, Macros), Minitab, and SharePoint; track wise (a plus)Previous experience writing and executing protocols