Technical Services Engineer

Website TPM05000

Our client is a bio pharmaceutical company based in Athlone looking for a Technical Services Manufacturing Engineer who will provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and future late stage clinical products at the facility.


  • Support technology transfers of new products into the Athlone Facility.
  • Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.).
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure.
  • Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting.
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
  • Collection, organisation, trending, and analysis of GMP manufacturing data.
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
  • Support establishment of validation plans and evaluation of drug substance/product production site options.
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated in the Athlone site.

Qualifications & Experience:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
  • Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
  • Experienced in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices.
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes (CQA).

To apply for this job email your details to