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Project Engineer Validation

Company: AlphOmega
Location: Decatur
Posted on: November 20, 2020

Job Description:

Minimum Bachelors Degree required 3+ years experience in the pharmaceutical industry, or equivalent experience required Experience in the pharmaceutical industry with a manufacturing background. Experience validating a wide range of equipment and processes (including cleaning processes), including mixing, sterile fill, freeze drying, parts washers, vial washers, depyrogenation, wet steam and dry heat sterilization and packaging. Experience and knowledge of qualifying changes to validated systems/processes/and equipment Knowledge of cGMPs and regulatory requirements as they relate to IQ/OQ/PQ/VQs responsible for all aspects of the validation process, including: documenting commissioning activities, establishing the process and equipment acceptance criteria developing and performing qualification studies to document evidence which provides a high degree of assurance that equipment and processes (including cleaning processes) will consistently produce a product meeting its predetermined specifications and quality attributes Operate Thermal Mapping Equipment Train other Validation personnel. Purchase supplies and equipment for validation activities. Administer the site Change Control Program Job Type: Full-time

Keywords: AlphOmega, Decatur , Project Engineer Validation, Engineering , Decatur, Illinois

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