Validation Engineer

Description:

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Note: Candidates should be available to start as soon as possible. Start date could change, to an earlier date, depending on when the right candidate has been identified.

ValidationEngineerwill be responsible for developing and implementing equipment (facilities, formulation/fill, packaging, and Quality Control), cleaning, sterilization, computer/automation, shipping, and methodvalidationstrategies by incorporating goodengineering practices, risk-basedvalidationprinciples and the regulatory requirements. TheValidationEngineerwill collaborate with internal and external customers by providing oversight and technical guidance throughout the system lifecycle. TheValidationEngineerwill continually ensure systems and facilities comply with regulatory and Quality process requirements. Major Responsibilities Participates in system design and commissioning project phases. Provides oversight and technical guidance for Facilities, Formulation/Fill, and Packagingengineers during Installation and Operational Qualification. GeneratesValidationProject Plan for complex projects and systems Supports Risk Assessments documentation including but not limited to, System Impact Assessments, Components Criticality Assessments, Data Integrity Assessments and Automation Risk Assessments AuthorsValidationProtocols and Reports for cleaning, sterilization, computer/automation, shipping and method processes. AuthorsValidationProtocols and Reports for Controlled Temperature Units. Supports Periodic Assessments on required frequency intervals Performs Revalidations on required frequency interval Resolves technical issues encountered during study execution Schedules resources to approve and executevalidationdocuments Participating in SOP development as needed Supports equipment start-up, shakedown, and cycle development Interacts with regulatory agencies during inspections to speak tovalidationprogram and questions related to processvalidationlife cycle Implements/maintains governing cGMP procedures Ensures training of employees and contractors to assure up-to-date knowledge of practices and procedures Author and review change control documents