Engineer Validation

GEA

  • Vadodara, Gujarat
Engineer Validation
Job Posted : Nov 2nd, 2023

Job Description

  • Prepare validation/qualification lifecycle deliverables such as Validation Plans, Requirements Specifications, Traceability Matrix, Summary Reports, Change Controls.
  • Ensure that the equipments are manufactured and following CE complaint/CE marked directives
  • Prepare, review and execute qualification/ validation protocols and associated reports while adhering to a regulatory requirement.
  • Develops written procedures for operation and maintenance of equipment.
  • Manages Validation deliverables for projects of varying scope and complexity.
  • Manages all lifecycle deliverables in the Validation of equipment and single / multi-user Computerized Systems.
  • Assist in development of Validation practices, procedures in adherence with pharma standards.
  • Maintains a positive relationship with all project team members, other departments and site customers while promoting a positive team

Qualification And Experience:-

  • Engineering Graduate (Chemical Engineering – preferred)
  • 3 – 5  years of Validation experience in FDA-regulated industry.
  • Excellent understanding of cGMP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
  • Should have worked on Validation documentation based on current GAMP, 21 CFR Part 11, EU and FDA regulations, CE directives
  • Should have effectively manage multiple tasks and activities simultaneously.
  • Experience executing equipment qualification documents.
  • Experience with technical writing and document development / generation.
  • Strong computer skills in Microsoft Office Application – Word, Excel, and Power point, and the ability to learn new software as required for validation.

Location:-

  • Vadodara, Gujarat.

Company Overview:-

GEA is one of the largest technology suppliers for food processing and a wide range of other industries. The global group specializes in machinery, plants, as well as process technology and components.
GEA provides sustainable solutions for sophisticated production processes in diverse end-user markets and offers a comprehensive service portfolio.

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