Senior Validation Engineer

Overview

Join to apply for the Senior Validation Engineer role at Katalyst CRO . Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer with the following duties :

Responsibilities

• Write Validation documents per Food Drug Administration (FDA) / Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment; write and execute qualification protocols for new equipment and decommissioning protocols for old equipment.
• Execute approved protocols per company Good Documentation Practices (cGDP) and in accordance with cGMP, CFR 21 Part 11, 210 and 211, European Union (EU) regulations EU Annex 11, ICH Q7, Q8, Q9 and other applicable regulations, procedures and standard industry guidance.
• Identify discrepancies that occurred during execution of IOPQ protocols during manufacturing and laboratory equipment qualification; identify impact of the discrepancies on protocol, equipment or product.
• Identify root cause and define corrective and preventive action procedure to resolve the deviations; write / draft discrepancy report; assist in performing non-conformance investigations for pharmaceutical manufacturing.
• Create / modify change control requests, project plans and maintaining project timelines; draft change control request and monitor changes throughout the project for new and existing equipment or procedures in accordance with company and FDA regulations; define and own all necessary change control objectives to decommission the current equipment or to install / qualify the new equipment.
• Perform system level risk assessments and data integrity assessments; perform Electronic Records / Electronic Signature (ERES) risk assessment; participate in review of manufacturing operational SOPs that apply to validated equipment.
• Author / review / approval of 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.
• Per FDA and other US pharmaceutical regulations; Analyze validation data, prepare reports and make recommendations for changes and / or improvements; review / approval process for validation documents in Veeva Vault / Documentum.
• Author and review responses to inspection observations and agency questions; author and review sections of regulatory filings and annual product quality reviews.
• Note : up to 40% remote work allowed.

Requirements

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