Life Sciences Qualification Engineer





Your role

As a Qualification Engineer your role consists of qualifying equipment from replacements to introductions of new equipment materials. You are active in multidisciplinary project teams, which results in a combination of autonomous tasks and teamwork engagements with colleagues of all sorts of departments. It is your mission to be and become a specialist in all Qualification activities.

  • You create and execute Qualification protocols, and report on the progress being made;
  • You make sure GMP standards are being implemented and make sure they are translated in Qualification activities;
  • You follow-up on all activities concerning the protocols, document the results, quality incidents and deviations;
  • You define the cause, effect and actions and make sure the preventive measures are documented and managed;
  • You present and defend the approach of the Qualification actions towards internal stakeholders;
  • You participate in Continuous Improvement projects;
  • You write operational procedures.

Your profile

  • You have a Master degree in a Technical domain or equal by experience;
  • You are familiar with GMP/GDP and have relevant experience with Qualification activities (writing URS, DQ, IQ, OQ, PQ protocols and reports, with testing and documentation, risk analysis, experience with P&ID's, etc.);
  • You have prior experience in a GMP environment, preferably Pharma, Biotech and/or Medical Devices;
  • Knowledge about safety documentation for Change Control would be an extra;
  • You write and speak fluent French or Dutch and English;

  • You have strong administrative skills, pragmatic, able to work both autonomously and in team, critical and focused on solutions.

Ref:

134196

Posted on:

May 23, 2022

Experience level:

Experienced

Contract type:

Full-time

Location:

Brussels