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SR Validation Engineer

  • Anywhere

Company :
Two95 International Inc.

Location :
New York City, New York

Expiry Date :
Sat, 06 Feb 2021 23:59:59 GMT

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Description :
Title SR Validation Engineer

Location: Remote Work Type: 6+ Months Contract Rate: Market Minimum Requirements:

* BS in technical discipline (Engineering, Chemistry, Microbiology, Biology).
* Years applicable experience in a quality support function specific to qualifications encompassing computer systems validation and at least two of the following areas: Equipment Qualification, Utility Qualification, Process Validation, or Cleaning Validation.
* Years’ experience in GMP pharmaceuticals, biologics and/or vaccine manufacturing.
* Knowledgeable in principles and current Good Manufacturing Practices (GMPs) in a development to commercial application setting.
* Strong knowledge foundation of FDA regulations regarding the manufacture and support of biologics (11, 210, 211, and 610 CFR).Experience in various validation topics which include Process, Cleaning, Equipment, Utilities, and IT systems.
* Experience in applying risk-based approach to Equipment/Utility/Computer Systems Qualification.
* Experience with and knowledge of related quality systems such as Change Control; CAPA (including Deviations/OOSs); Training; and Document Control.