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AA2IT
West Point, PA | Contractor
$71k-100k (estimate)
3 Months Ago
AA2IT
West Point, PA | Contractor
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AA2IT
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Integrated Resources Inc
West Point, PA | Contractor
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Eurofins PSS Insourcing Solutions
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Eurofins PSS Insourcing Solutions
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Eurofins Agroscience Services
West Point, PA | Full Time
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Deviation Management Specialist
AA2IT West Point, PA
$71k-100k (estimate)
Contractor 3 Months Ago
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AA2IT is Hiring a Deviation Management Specialist Near West Point, PA

Location: 770 Sumneytown Pike, West Point PARate: $41/Hr
QualificationsEducation Minimum Requirements:
  • B.S. degree in Engineering or Sciences.
Required Experience And SkillsMinimum 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 <1 year experience).
  • Demonstrated ability to drive results to hit assigned due dates.
  • Strong communication, collaboration skills and ability to drive accountability.
  • Strong problem-solving skillsetMust Have Skills
    • Vaccine manufacturing
    • Sterile processing
    • Experience authoring
    ResponsibilitiesThe Deviation Management individual will be responsible for deviation management activities in support of vaccine production at the West Point site. This engineer will be a member of the Technical Operations Deviation Management team within the ROTA End-to-End (E2E) technical operations unit. The primary responsibility of the individual will be investigation initiation and closure associated with vaccine technology/production in support of the operations taking place in the ROTA E2E. Support will be focused on the Deviation Management process including operations support, equipment troubleshooting, implementation of process/equipment actions, and other related duties. This position will require development of technical expertise of process and product knowledge. This is position is a site-based assignment and requires the employee to work at the site M-F. Two days of remote work per week may be available, work permitting, but is not guaranteed. Off-shift or weekend coverage may be required based on business unit needs and specific assignments.
    Responsibilities Include
    • 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.
    If Interested ; kindly share your updated resume with Answers.
    a-How many years of exp in ( e.g. Production, Development, Process Engineering, Technical Services or related field) pharmaceutical/ biotech industry
    b-How many years of exp in reduction of process deviations, development and implementation of corrective/preventative actions, and leading manufacturing and laboratory investigations
    c-How many years of exp in Technical writing - this exp is very much preferred
  • Job Summary

    JOB TYPE

    Contractor

    SALARY

    $71k-100k (estimate)

    POST DATE

    03/24/2023

    EXPIRATION DATE

    06/23/2024

    Show more

    AA2IT
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