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CQV Engineer

  1. Denmark
Copenhagen
  1. Contract
Competitive
  1. Life Sciences
10-05-2023
31258

This vacancy has now expired

CQV Engineer – Life Sciences- Contract- Copenhagen

Our exciting biopharma client based in the Nordics require the support of a CQV Engineer for a 12 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.

 
CQV Engineer Responsibilities:
  • Responsible for the preparation and execution of the packaging equipment as part of the project team
  • Review documents relevant for qualification from vendor
  • Attend to FAT and SAT
  • Supervise the vendor during vendor qualification activities (SAT, IQ, OQ)
  • Prepare and execute specific DQ, IQ, OQ and PQ. PQ to be done in cooperation with manufacturing
  • Authoring discrepancies reports and punch lists. Contribute to investigations of discrepancies arising during qualification activities and approval of appropriate corrective actions
  • Documentation to comply with GDP/GMP when performing commissioning and qualification testing
About you:
  • Technical education or higher in a related technical discipline 
  • At least 5 years’ experience with commissioning and qualification
  • Experience of packaging equipment within pharmaceutical industry
  • 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 the qualification of packaging equipment in the pharmaceutical industry
  • Communication skills, both written and oral
  • 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 CQV Engineer? Apply today.

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

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