Technical Services Engineer (Product/Process) - Galway - 12 Month ContractAre you looking for the opportunity to work alongside a global pharmaceutical organisation in Galway? Our esteemed client is looking for a Technical Services Engineer to join their team in their existing manufacturing facility in Galway. The facility is a responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for a Technical Services Engineer to help maintain manufacturing operations.What you'll do:
Strong knowledge of aseptic processing, terminal sterilization, and lyophilization.Experience with process validation (PPQ), DOE, and statistical process control (SPC).Proficiency in cGMP, Annex 1, FDA, EMA, and ICH guidelines for sterile products.Proficient in the generation of cGMP documentation e.g. protocols, report, change control etc.
What you'll need:
Extensive experience in pharmaceutical manufacturing or process engineering, with experience in sterile injectables or biologics.Strong working knowledge of aseptic processing, including lyophilization, terminal sterilization, and isolator-based filling operations.Hands-on experience with process validation (PPQ, CPV), risk assessments (FMEA), and root cause analysis.Proficiency in regulatory compliance: cGMP, Annex 1, FDA, EMA, and ICH guidelines.
If this role is of interest to you, please apply now! #LI-AE1