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Details

Tech Transfer Engineer:


Reference:RH A003121 Location: Dublin South
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Life Science Recruitment are recruiting for a Tech Transfer Engineerto join the team with our Biopharmaceutical client in South Dublin.


This role will require the candidate to provide process development support to new product introductions (NPI) and lifecycle changes to site, contribute to subject matter expertise for unit operations and support ongoing production.

The candidate will provide technical support to large molecule and small molecule drug product manufacturing on site as well as part of the global Process Development organization.

The input provided will also include support of process performance and implementation of process improvement strategies and will include the following:



Role/Responsibilities:

  • Contributes to new product introductions and lifecycle changes to PM2 and PM3 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer to PM2 or PM3.
  • Be a contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also contribute to responses to regulator questions as and when required.
  • Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization, inspection, and transportation for parenteral products through the NPI or post-NPI phases.
  • Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
  • Assists in the development and characterisation of drug product processes and transfers technology to commercial drug product sites.
  • Identifies and implements operational opportunities for current and new sterile operations.
  • Troubleshoots issues with drug product processing technologies and equipment.
  • Conducts risk assessment for drug product operations and proposes / implements appropriate CAPA.
Education and Experience:
  • A third level Bachelor’s degree in Science or Engineering with 3-5 years’ experience in a similar role.
  • Knowledge of cGMPs and other worldwide regulatory requirements
  • Problem solving ability and excellent oral and written communications skills
  • 5 years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
  • Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry regarding chemical and physical stability
  • Knowledge of Quality systems, Drug Product Manufacturing and Validation.
  • Demonstrated ability working cross-functional teams to advance complex projects to completion. Excellent Communication skill is essential for this role.
For more information contactRuth Hollandon087 7822 198orruth.holland@lifescience.ie