Process Engineer

2 weeks ago

Cork, Cork, Ireland Prochem Engineering Full time

Role Purpose:

  • A new opportunity has arisen for a Process Engineer to join our client's busy biopharmaceutical facility in Co. Waterford.
  • The successful candidate will provide Process Engineering support to existing business as usual daily functions and on-going continuous improvement prefilled syringe processes.

Core Duties and Responsibilities:

  • The main area of work is in acting as Process Engineer for project/ programs associated with pre-filled syringe operation. Process engineer scope of works will involve, but is not limited to:
  • Filter test development
  • Fill weight cycle development
  • Cleaning verification
  • Documentation Generation/Execution eg. Recipe documents, FMEAs, Protocols, Reports etc.
  • Leading problem-solving investigations for technical issues as well as owning change controls.
  • Delivering activities on schedule and within budget.
  • Supporting day-to-day operations of the syringe filling area through investigations, identify and deliver corrective actions including continuous improvement projects.
  • Communicate and liaise with material/component vendors during project.
  • Execute Process Engineering activities to schedule and to the appropriate compliance and safety standards.
  • Writing of Process/Operational Control Strategy documents (detailing control over Critical Process Parameters), Failure Mode Effect Analysis (FMEA) and supporting Operator training.
  • Coordinating and ownership of deliverables to meet project timelines and cost.
  • Generation of hour-by-hour schedules for planning line time and execution of deliverables.
  • Provide support where required on the existing Aseptic Syringe Filling Line and supporting processes which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
  • Support commercial manufacturing through delivery of key performance metrics (SQDCI).
  • Role may require travel to other Company sites or vendor sites.
  • Participate in site GMP regulatory and safety audits.
  • Provide technical support to implement process improvements, new product transfers to the site and production.

Education & Qualifications Required:

  • Honours degree in an Engineering discipline.
  • 3 or more years' relevant experience in a highly regulated GMP environment.
  • Strong problem-solving skills.
  • Experience of Sterile Manufacturing Operations would be an advantage.
  • Experience in syringe filling would be a distinct advantage.
  • Experience in new product introduction would be a distinct advantage

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