Job Description
Shire Human Genetic Therapies Inc. requires a Senior Validation Engineer responsible for authoring and reviewing commissioning, qualification, and validation lifecycle documents such as User Requirement Specification (URS), Functional Requirement Specification (FRS), Risk Assessment, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols, Requirement Traceability Matrix (RTM) and Validation Summary Reports (VSR) etc. The engineer will analyze validation data, prepare reports and provide recommendations for changes and/or improvements, alongside reviewing and approving validation documents in Veeva Vault Documentum. Furthermore, they will author and review responses to inspection observations and agency questions, and contribute to sections of regulatory filings and annual product quality reviews.
About Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.