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Validation Employee

Place of work


Job description

Main Activities expected by the Job:

  1. Proactive management of GMP changes related to Site Equipment, Facilities, Utilities, Processes, Materials, in a highly regulated and stimulating environment.
  2. Managing the discussion of proposed changes with both the proposer and the Validation Manager prior to their incorporation into the informatics system. This discussion aims to highlight pertinent technical aspects such as feasibility and expected timelines.
  3. Following the integration of the change into the system, the individual will collaborate closely with subject matter experts from Quality Control (QC), Quality Assurance (QA), Engineering, and Production to ensure its successful implementation. This entails verifying that all predefined quality requirements are duly met.
  4. To issue and/or review associated validation documentation packages. These packages may include, but are not limited to, Validation Plans, Summaries, Quality Reviews, and Validation Protocols.
  5. To assume responsibility for the execution on the field of PQ (Performance Qualification) activities.


Technical Skills expected by the Job:

  • Technical Writing
  • Validation and Change Control
  • Aseptic Filling Principles


Behavioral Skills Expected by the Job:

  • Team working
  • Analytical thinking
  • Project planning


Computer Skills expected by the Job:

  • Good knowledge of MS Office (Word, Excel, etc.)


Languages Skills expected by the Job:

  • Good level of spoken and written English (desired level: B2 or C1)


Mandatory Requirements of the Job:

  • Master’s degree in Engineering (mechanical, chemical, informatic)
  • Italian mother tongue or native proficiency





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