Process Engineer

3 weeks ago

Cork, Cork, Ireland KPC International Full time
KPC International - Excellence from Concept to Completion

Process Engineer - Waterford

KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.

We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.

We are looking for a Process Engineer to provide support to existing business as usual daily functions and ongoing continuous improvement pre-filled syringe processes. Support in the manufacturing of monoclonal antibody (mAb) commercial products, support technology transfer of new products, support introduction of capacity enablers and to work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

The project is based in Waterford and is a 12-month contract with the possibility of extension. This is an onsite role.

Main Duties Will Include

The main area of work is 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 (e.g., 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.
Additionally, the role will require:
  • Supporting day-to-day operations of the syringe filling area through investigations, identifying and delivering corrective actions including continuous improvement projects.
  • Communicating and liaising with material/component vendors during projects.
  • Executing 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 owning deliverables to meet project timelines and costs.
  • Generating hour-by-hour schedules for planning line time and execution of deliverables.
Essential Skills / Qualifications
  • Honours degree in an Engineering discipline.
  • Strong problem-solving skills.
  • 3 or more years of relevant experience in a highly regulated GMP environment.
  • 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.
KPC International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others. KPC International is an Equal Opportunity Employer.
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