Sr. Process Validation Engineer

Roles & Responsibilities :

• Minimum years of CQV experience in a parenteral fill / finish environment.
• Lead process validation projects of broad scope.
• Responsible for project deliverables such as VMPs, pFMEAs, PPQ protocols and reports, change control assessments, technical transfer assessments, as well as other client deliverables as required.
• Provide technical support to Manufacturing – troubleshooting and resolving process related issues.
• Participate in investigations and provide documentation for Deviations and CAPA based on OOS / OOT results or validation activities.