Validation Engineer

Posted 3 days ago

infotree global solutionsGaithersburg (MD)

SENIORITY

Lead

About the role

Job Description:

The Validation Engineer will be responsible for developing and implementing equipment (facilities, formulation/fill, packaging, and Quality Control), cleaning, sterilization, computer/automation, shipping, and method validation strategies by incorporating good engineering practices, risk-based validation principles, and regulatory requirements.
The Validation Engineer will 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.

Job Responsibilities:

Participates in system design and commissioning project phases.
Provides oversight and technical guidance for Facilities, Formulation/Fill, and Packaging engineers during Installation and Operational Qualification.
Generates Validation Project Plans 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.
Authors Validation Protocols 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 execute validation documents
Participating in SOP development as needed
Supports equipment start-up, shakedown, and cycle development
Interacts with regulatory agencies during inspections to speak to validation program and questions related to process validation life 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

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