Validation Engineer

Łęg / Jelcz Laskowice, Poland
Posted 8 months ago

As a Validation Engineer, you will plan, implement and monitor the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. You will measure and analyze the process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result to ensure the highest quality products are produced.

You will be responsible for:

  • Participating in the activities aimed at updating the Validation Master Plan,
  • Assessing the risk in production processes,
  • Preparing documentation for validation process (URS, IQ, OQ, PQ), in compliance with the requirements of the FDA and ISO 13485 standards,
  • Keeping the validation records,
  • Supporting the team responsible for the fulfilment of tasks during the process of validation of production machines, equipment and processes,
  • Assessing the results and preparing validation reports, and their archiving,
  • Providing support in the scope of removal of cases of non-compliance in validation processes,
  • Assessing the grounds and supporting in the scope of revalidation,
  • Assessing new machines, equipment and processes in terms of necessity to perform validation,
  • Preparing and running training in validation processes.

Your required profile:

  • At least 2-year work experience in engineering positions related to validation and/or quality processes,
  • Higher technical education (production engineering, production management, technical physics, quality management/manager, electronics, automation and robotics, and related fields),
  • Knowledge of issues in the scope of the validation process and machines,
  • Knowledge of quality management systems, ISO 13485 and FDA,
  • Knowledge of statistical methods is an additional asset,
  • Very good computer skills in the scope of Excel,
  • Knowledge of the English language sufficient for unhindered communication,
  • Knowledge of MS Office Package

We will offer:

  • Permanent employment in developing the international organization
  • Competitive salary and various benefits
  • Independent role with many interesting challenges
  • Possibility to work on very important position
  • Friendly atmosphere directed at people
  • International, respectful and friendly environment
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