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Senior Operations Specialist - Biotech Expansion

Manufacturing / Production
Carlow
Therese Keohane
Permanent
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Job Reference: JO-2004-65110_1590067871

Summary:

A fantastic career opportunity has arisen with a leading Biopharma M/N in the South East for a Senior Operations Specialist to guide the development of a new expansion project and contribute to the effective and safe manufacture of life enhancing products for patients globally.



RESPONSIBILITIES



  • Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers

  • 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

  • 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

  • Effectively lead the media fill (Process Simulation) development and execution

  • 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 OPs


Requirements:



  • Degree qualification or equivalent (Science, Engineering, Technical)

  • 10 + years' experience in GMP manufacturing with experience within high speed aseptic filling lines and formulations areas

  • 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



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Talent Consultant:
Therese Keohane
Therese Keohane
Business Unit Lead
Quality & Laboratory
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