Deviation Management Specialist I

1 week ago


West Point, United States Joulé Full time
Job Title: Deviation Management Specialist - I

Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.
Location: West Point, PA
Hours/Schedule: M-F; 1st Shift
Type: Contract

Overview
Global Vaccine Manufacturer looking to hire experienced Deviation Investigator to their growing team

Responsibilities Leads and/or works as a team member on manufacturing investigations and/or process improvement projects.
Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to identify root cause and propose effective corrective and preventative actions (CAPAs).
Assures consistent application of standardized work, engineering, and process tools.
Provides technical support to manufacturing shop floor for problems and issues.
Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
Writes technical documents to support closure of deviations using the SAP system.
Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.

Requirements B.S. degree in Engineering or Sciences.
Minimum one (1) year post-bachelor’s degree experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with
Demonstrated ability to drive results to hit assigned due dates.
Strong communication, collaboration skills and ability to drive accountability.
Strong problem-solving skillset
Preferred Experience and Skills:
Vaccine manufacturing
Sterile processing
Experience authoring

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

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