Validation Engineer

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Location : Cumming, GA

Duration : 6+ months

Date Posted : 05/23/2022

Position : W2

Job Responsibilities:

  • Create a validation package (i.e. Validation Master Plan (VMP), process flow diagrams, Standard Operating Procedures (SOPs)) for the manufacturing application systems in manufacturing and/ laboratory departments.
  • Develop System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process and/ FDA regulations.
  • Develop and review validation deliverables like User Requirement Specification (URS), Functional Requirement Specification (FRS)
  • Develop technical documentation such as Configuration Specification (CS) and Design Specifications (DS) in coordination with Technical Lead.
  • Design validation testing and execute protocols such as Installation, operational and performance documentation. Resolve testing problems by modifying testing methods or revising test objectives and standards.
  • Ensure the manufacturing system(s) complies with FDA and ISO regulations.
  • Perform statistical analysis and validation of data being migrated to new systems and validate test data to determine whether data migrated has met the predetermined validation criteria and identify the root causes of data load errors problems, if any.
  • Ensure Good Automated Manufacturing Practices (GAMP), which is a part of FDA Predicates Specifically 21 CFR parts 210/211/820 are followed while implementing manufacturing applications.
  • Follow change management processes and ensure adherence to both internal and by FDA regulations for all the project related activities.
  • Develop Validation Summary Report (VSR) to document all the validation deliverables, project deviations and resolutions.
  • Ensure all the SDLC phases and validation deliverable are in compliance with FDA and company standards

Qualification :

This position requires a candidate with a minimum of Bachelor’s degree in Industrial Engineering or a closely related field.

Travel : Travel involved to client location(s) within US as needed.

Job Tags : Validation Engineer, VMP, URS, FRS, GAMP, FDA, ISO, 21 CFR Part 11, Part 210, Part 211, Part 820, CS, DS, IQ, OQ, PQ, VSR