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Process Engineer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Quality & Compliance
  • Date posted: 10/10/2018
  • Job reference: BBBH15111

Process Engineer

Process Engineer required to join a leading biopharmaceutical company in the South East. This role is to provide Process Engineering input and overall project support for the aseptic processing of sterile biopharma products.

Responsibilities:

  • To work as part of a highly focused and integrated Process Engineering Team in a Sterile Manufacturing environment.
  • Execute Process activities to schedule and to the appropriate compliance and safety standards.
  • Support vendor management, construction management and qualification as the project progresses.
  • The main area of work would be on the Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies using CIP/SIP capabilities.
  • Provide engineering support to other areas of the PFS process such as Dispensing, Formulation, Autoclaving and Washing.
  • Provide technical expertise for the introduction of single use technology.
  • Prepare and Execute Commissioning /Qualification/Cycle Development protocols.
  • To generate, review and approve design deliverables produced internally and by external engineering service providers:
  • Ensure deliverables are fit for purpose and meet sites operation, safety and quality needs as part of a multi-disciplined team.
  • Be accountable for project safety and quality, progress, schedule and cost, individually and collectively.
  • Liaise with site quality, engineering and operations teams to ensure strong communication and support from the wider site.
  • Delivery of key performance metrics within the project.
  • Provide technical support to implement process improvements, new product transfers to the site and production.

Qualifications/Experience:

  • Honors degree in an Engineering discipline.
  • Knowledge of manufacturing environment.
  • Capable of working in a fast-paced project environment
  • Strong analytical problem solving skills.
  • Excellent communication skills
  • Strong interpersonal and leadership skills.
  • 3 or more years' 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.

For more info on this and other similar roles contact Kathryn on 01 6455250 or email kathry.whyteATexperis.ie