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Senior Operations Specialist

Reference:A007324 Location: Carlow
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Operational Excellence Lead

This is an exciting opportunity to join a leading pharmaceutical company in Carlow. As the Senior Operations Specialist, you will provide leadership, cross-function support and technical expertise to the team.

Reporting to: Associate Director

Your responsibilities:

  • As the Senior Operations Specialist, your responsibilities will include: the meeting of all end user requirements, ensuring that all equipment has incorporated all lessons learned, in addition to efficiencies put in place in the existing production areas.
  • Facilitate / Lead Quality Risk Management (QRM) introduction, ramp up and workshop participation for all IPT processes.
  • Assist the team with development of objectives and ensures alignment with site goals.
  • Responsible for the ensuring 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
  • Drive continuous improvement by leading and actively participating in process improvement identification and system failure investigations as well as investigation reports, execution/development of change control, decision trees and contribution to Kaizen events as appropriate.
  • Manage root cause analysis of system failures, using standard tools and methods, to resolve process and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc. Oversee and implement subsequent corrective action through the change management system.
  • Drive compliance with our Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Effectively lead the media fill (Process Simulation) development and execution
  • Work collaboratively to drive a safe and compliant culture.
  • 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
    • Q.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 OPs

What you need:

  • Degree qualification or equivalent (Science, Engineering, Technical).
  • 10 years’ experience in a Fill Finish/Sterile Environment
  • Minimum of 10 years working in a GMP environment with proven ability to drive projects and deliver results.
  • Experience in aseptic manufacturing.
  • Evidence of continuous professional development is desirable.
  • Proven Leadership capability, strong influencing skills and ability to work cross-functionally.
  • Previous experience in design, commissioning and qualification of manufacturing equipment to meet end-user needs a distinct advantage.
  • Experience of use of operational excellence and project management tools and a proven continuous improvement mindset.
  • A detailed understanding of the operational and quality systems required to ensure successful manufacturing.
  • Demonstrable analytical and systematic problem-solving skills
  • Operational experience within high speed aseptic filling lines and formulations areas
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Sterile filling processes and equipment
  • Pharmaceutical and Biotechnology manufacturing processes
  • Proficiency in Microsoft Office and job-related computer applications required