Science, Pharmaceutical & Food

Process Engineer – Fill/Finish

  • Contract
  • Remote
  • Carlow
  • 41832542

ROLE RESPONSIBILITIES

  • Deliver a strategy in line with current best practices to ensure best in class Aseptic Excellence throughout Form / Fill Finish activities
  • Responsible for Operational Readiness for all primary aseptic manufacturing (inclusive of Process Simulations) and development of cross functional strategies to build compliance and efficiencies into each process
  • Effectively lead the Process Simulation development and execution
  • Troubleshoot complex drug product fill / finish problems and use extensive experience to adopt or propose robust solutions.
  • Provide hands-on direction for Aseptic/Sterile Fill Finish cGMP manufacturing activities and actively coach in Aseptic Excellence
  • Actively network internally and externally with a view of promoting the site that’s viewed and recognised as a leader in Aseptic manufacturing of Vaccines and Biologics
  • Ensure provision of operational support for key projects in facility commercialisation, including but not limited to installation of new filling line, deployment of Quality Risk Management processes and Quality/Operational Systems improvement
  • Facilitate / Lead Quality Risk Management (QRM) introduction, ramp up and workshop participation for all IPT processes Senior Operations Specialist for the Carlow
  • Develop and facilitate a program that improves, drives and tracks IPT commercial readiness, ramp-up and improvement in the following areas:
    • Batch Release
    • Turnarounds between batches
    • Downtime tracking, OPR and Action follow up
    • C hand offs – Sampling/process improvements
    • Versatility chart and cross functional training competency
    • Documentation review (delta V, qualifications)
    • MES Version 3 implementation
    • Focus on right first time – real time review
    • E2E materials readiness and movement
    • Simplification of Critical process steps
    • MES/Delta V competency – hand off from the systems to Operations

QUALIFICATIONS & EXPERIENCE:

  • Degree qualification or equivalent (Science, Engineering, Technical) most desirable.
  • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
  • 10 years’ experience in a Fill Finish/Sterile Environment / working in a GMP environment with proven ability to drive projects and deliver results.
  • Strong team skills, including ability to coach/develop work teams.
  • Strong influencing skills.
  • Operational experience within high speed aseptic filling lines and formulations areas.
  • Degree qualification or equivalent (Science, Engineering, Technical).
  • Experience in aseptic manufacturing with extensive technical expertise in Aseptic Techniques and Form / Fill Finish.

If interested please contact Seán on 021-4297900 or sean.molloy@peglobal.net

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