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Qualification Engineer

  1. Denmark
  1. Contract
Competitive
  1. Life Sciences
10-05-2023
31259
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Qualification Engineer – Smoke Studies- Life Sciences- Contract-Copenhagen

Our exciting biopharma client based in the Nordics require the support of a Qualification Engineer for a 3 month contractual basis. This role is based in a beautiful location with good transport links, a full expense package included, and competitive hourly rates.

If you want to help an innovative biopharmaceutical company driving the manufacture of biosimilars, and temporarily work within the stunning surrounds that the Nordics offer, this is the role for you.


Qualification Engineer – Smoke Studies Responsibilities:
  • Perform and support the execution of smoke (air visualisation) studies on an aseptic filling line (“at rest”, “in operation”, machine set up, and interventions).
  • Execute the study in co-operation with local qualification engineer.
  • Required equipment (e.g. smoke generator, camera) is available on site
  • Operation, set up of filling line and performance of the aseptic interventions is done via manufacturing personnel
  • Ensure the compliant execution of the smoke study
  • Answer questions from QA related to the executed study

About you:
  • Technical education or higher in a related technical discipline
  • At least 5 years’ experience with execution of smoke studies in aseptic filling lines
  • Knowledge of key GMP processes, e.g. documentation, qualification, change management, user requirement specifications, IQ/OQ/PQ execution
  • Knowledge of and experience with GMP documentation and handling of discrepancies
  • Knowledge and experience for autoclave qualification of advantage
  • Knowledge of regulatory requirements associated with smoke studies in aseptic filling lines
  • Communication skills, both written and oral
  • Strong interpersonal skills
  • Good attention to detail and strictly adherence to SOPs
  • Good time planning (stick to timelines)
  • Protocol/report writing skills

Are you a good fit for a Qualification Engineer –Smoke Studies? Get in touch with us today.




The candidate must have the rights to work in the location stated in the job advert.

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