API Subject Matter Expert (SME) – New Project

  • Contract
  • Dublin

Website Ref:tPM04629

Summary:
Our client is seeking an API expert to be the technical point of reference for pharmaceutical chemical manufacturing projects. The incumbent will be responsible for selection design and start-up of GMP process equipment and its performance delivered at cost and schedule. The candidates will have direct impact selecting and integrating technologies to establish effective API manufacturing operations and value to the patients.

Responsibilities:

  • Supporting the API manufacturing expansion project based near Dublin, Ireland.
  • This position is expected to be full time on site with potential travel and visits to design firm during basis of design and detailed engineering phase and visits to critical suppliers for machine assembly inspection, pre FAT, and FAT.
  • Technical governance throughout the project lifecycle.
  • Lead a collaboration with site cross functional team and engineering firm to design and specify critical technical packages including P&ID’s, URS’s and design qualifications to meet our client’s business requirements.
  • Support process risk assessments (HAZOP-LOPA, FMEA) in order to establish and deliver safe process operations and meet drug substance quality requirements.
  • Support procurement’s strategic supplier management efforts, establish qualified suppliers and bid evaluations.
  • Working with technology leading equipment suppliers, Design Engineering and Construction firms to successfully deliver state of the art integrated API manufacturing operations.
  • Providing construction phase technical audits and lead GMP equipment testing and FAT’s including authorisation to release equipment from supplier to client site.
  • Providing technical support to equipment commissioning and validation.
  • Coordinate critical technical documents reviews and approvals from engineering firm or equipment supplier with site cross functional team and process SME’s.

Qualifications & Experience:

  • Degree calibre Chemical Engineer with experience in Chemical API operations.
  • In-depth knowledge of API equipment including reactors and Nutsche type vacuum filter dryers.
  • Ability to work in a cross functional team environment with both internal and external collaborators.
  • Experience in the specification, procurement, installation, start up and commissioning of API equipment in a licensed GMP commercial plant.
  • Experience with capital project delivery from business case development through project execution and current GMP regulations.

To apply for this job email your details to orla.daly@tandempm.ie.