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Process SME

  1. Sweden
Stockholm
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37093
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Process SME - Stockholm, Sweden - 12 Months Contract

How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this is the assignment for you!

Our client is currently seeking the skills of a Process SME to join their team. Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Technology selection, capacity calculations (process modelling), and preliminary equipment sizing.
  • Ensure User Requirement Specification (URSs) are produced and completed technically accurate and appropriate for calibration & qualification execution.
  • Lead process risk assessments in order to establish and deliver safe process operations and meet drug product quality requirements.
  • Support procurement supplier management efforts to establish qualified suppliers and bid evaluations.
  • Work with technology leading equipment suppliers, Design Engineering and Construction firms to successfully deliver an integrated manufacturing operation.
  • Review and approve process technical documents from design and equipment supplier firms.
Desirable Experience:
  • Understanding and/ or experience with spray drying platforms for inhalation products.
  • Technical understanding of basic OSD unit operations.
  • A natural communicator with excellent partner engagement & leadership skills.
  • Experience in the specification, procurement, installation, start up and commissioning of GMP equipment.
If this role is of interest to you, please apply now!
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