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Looking for Automation Engineer ||Hybrid|| at Wilson, North Carolina, USA
Email: [email protected]
From:

Rahul Raghuvanshi,

TEK Inspirations LLC

[email protected]

Reply to:   [email protected]

Hi,

Hope you are doing well.    

Title: Automation Engineer

Location: Wilson, NC (Hybrid)

Visa: USC/GC

Duration: 12 Months Contract

MOI: SKYP

Job Description:

Bachelor's degree in Science, Information Technology, Engineering or equivalent
5 years of experience in regulated pharmaceutical manufacturing industry
3 years of experience delivering validated IT solutions or in application support role in regulated environment
Strong understanding of current pharmaceutical industry and regulations (FDA/EU/ICH)
Extensive knowledge of principles, theories, and concepts of computerized system validation/compliance
Practical experience in implementing quality systems in pharmaceutical, laboratory, or biotechnology manufacturing environment

Job Responsibilities:

Lead/Develop/Use Key Process Indicators to monitor process effectiveness
Review audit and assessment reports and ensure audits are performed to high client satisfaction and within budgeted time
Review assessment findings and action plans to ensure compliance
Ensure selected technologies meet high-level business needs and encourage innovation and efficiency
Interface with MMD IT and other entities to align GMP shopfloor, laboratory, and quality system technology capabilities with quality policies and objectives
Provide independent quality approval of key qualification/validation documentation
Ensure site/above site system owners have Operating Level Procedures/Plans in place to keep computerized systems validated
Review processes and supporting evidence to verify compliance activities related to computerized systems
Support regulatory inspection and audit activities as needed

Keywords: information technology green card North Carolina
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Fri Feb 10 23:15:00 UTC 2023

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Location: Wilson, North Carolina