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ID #12158778
State North Carolina
City Wilson
Job type Contract
Salary USD $50 - $70 per hour 50 - 70 per hour
Source Manpower Engineering
Showed 2021-04-12
Date 2021-04-12
Deadline 2021-06-11
Category Et cetera
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Validation Engineer

North Carolina, Wilson, 27893 Wilson USA

Vacancy expired!

Validation Engineer-Computerized Systems Validation

6+ month contract/project position with liklihood of extension and outside chance of conversion. 5+ yrs experience in computer system validation. Position onsite in Wilson NC. Must be eligible to work in US. Citizen or Permanent Resident only. No sponsorship available.

Job Description: Develop and execute Computerized System Validation (CSV) deliverables for control systems for production equipment including but not limited to Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Trace Matrices, Test Execution, Summary reports. CSV will be specific to automated process equipment and interfaces.

Requirements:

Education: Bachelor's degree in Engineering or related science studies.

  • Prefer five (5)+ years related work experience including strong knowledge and hands-on experience of computer system validation (CSV) activities in the regulated industries.
  • Strong technical writing skills

Essential skills:

Understanding and experience with CSV regulations and guidelines such as FDA; cGMP for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance with CGMP Guidance for Industry; and ISPE GAMP5.

  • Strong knowledge of the development and execution of CSV deliverables throughout the System Development Life Cycle (SDLC)
  • Knowledge, familiarity and exposure to industrial control systems (PCS, Siemens PLC, or related), including related configuration/programming.
  • Strong technical writing skills

Vacancy expired!

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