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Scientific. Clinical. Software Engineering

Snr Validation Engineer

Philadelphia Metro Area, PA

Job Type: Scientific Job Number: JN -022020-26465 Region: Philadelphia Metro Area

Job Description

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 the regulatory requirements. The Validation Engineer will collaborate with internal and external customers by providing oversight and technical guidance throughout the system lifecycle. The Validation Engineer will 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 Packaging engineers during Installation and Operational Qualification.

generates Validation Project 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

Authors Validation Protocols 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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