Process Validation Engineer

Description

Responsibilities include the following. Other duties may be assigned. Production process design Own the manufacturing processes Write / amend work instructions or SOPs as needed. Lead major projects as a technical resource (major process changes, etc.). Identify and implement systemic improvements. Support cleaning validation and revalidation efforts. Monitor production for quality, yield, and rate. Leads a project team for the development, execution and summarization of Process Validation protocols, Cleaning Validation protocols, IQ protocols, OQ protocols, PQ protocols and Commissioning plans with the support of Operations personnel. Leads a project team for the execution of approved Technology Transfer and Submission Batch protocols Sources Vendors and Contractors to support Validation Department projects Leads Factory Acceptance Test (FAT) teams at Vendor sites Writes project status reports for communication with the Validation Manager Prepares project schedules in MS Project, utilizing formal project management techniques Writes other reports and correspondence as required. Reviews, amends, and writes applicable SOP's. Assures cGMP and SOP compliance