Validation Specialist

2 days ago


Port Washington, Wisconsin, United States Adecco Full time
Job Title: Validation Engineer

The Validation Engineer plays a crucial role in ensuring the quality and compliance of our products by developing and executing protocols, equipment, and processes to meet FDA and regulatory requirements.

Key Responsibilities:
  • Develop and execute installation, operation, and performance qualification protocols and summary reports for processing equipment, utilities, computerized systems, and laboratory equipment.
  • Develop and execute product validation protocols.
  • Develop and execute cleaning validations.
  • Perform training and write Standard Operating Procedures (SOP's) / Work Instructions.
  • Interface with customers and maintain good documentation practices.
  • Communicate effectively with cross-functional groups to meet compliance requirements and release goals.
  • Assist in the maintenance of the Validation Master Plan (VMP) and Cleaning Validation Master Plan (CVMP) schedules throughout the organization.
Requirements:
  • Associate or bachelor's degree with a strong emphasis in a natural science or engineering.
  • Excellent communication skills (written and verbal) to write reports and findings and present to all levels of management in a clear and concise manner.
  • Strong project management skills and familiarity with regulatory and GMP requirements for pharmaceutical manufacturing operations.
  • PC proficiency to include Microsoft Office (Word, Excel, Access, PowerPoint) along with Google Suite and Microsoft Outlook, statistical analysis software, and contract management software.


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