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Brunel belgium

Compliance Engineer

ANTWERPEN - Industry - Machine & Equipment Construction - Health, Safety, Environmental & Quality - Academic Master
Staat 11 dagen op

Compliance Engineer


Provide compliance (validation/qualification ) support for GMP and EHS critical changes to production systems and facilities and provide support to ensure these systems remain in a GMP compliant state:

  • Changes initiated by production or maintenance
  • Changes initiated by project engineering groups (MAM , E&PS )
  • Periodic reviews on the system?s documentation to ensure these systems remain qualified (3year period)
  • Evaluate calibration deviations and initiate, follow up on and document corrective actions to bring instruments back in compliant condition.
  • Preparation of intakes. (Sr only)
  • Update data in compliance follow-up tools ( eg Trackwise, ? )
  • Closely work with client?s engineers and plant representatives
  • Awareness of client?s compliance procedures by following client?s trainings


  • Needs to have sufficient knowledge of equipment qualification on GMP systems for production of API ?s
  • Knowledge of supporting data systems such as Trackwise and TruVault are advisory.
  • Problem-Solving:A technical background is required , person must have feeling with the involved equipment : Dryers, Pumps , Powder units, piping , centrifuges, ?
  • AccountabilityEach teammember must be aware that poor performance is directly affecting these KPI?s , resulting in a malus or bonus.
  • Bachelor or Master degree
  • Approximately 1 to 5 years of experience in pharmaceutical industry in qualification/compliance activities
  • Teamplayer
  • Dutch: native language
  • English: fluent in reading ? good in writing
  • Committed to this role for at least 2 years
  • Knowledge of systems as SAP , Trackwise, E-stream, Truvault is a plus


We offer you an interesting project at one of our international clients.
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