Specialist for our client**Apply on the website**;s expansion
project at its biologic facility in Leinster. This senior role
requires extensive experience in aseptic fill-finish operations.
Reporting to the Associate Director of Operations, this person will be
responsible and lead operational readiness for all primary aseptic
manufacturing.
Main 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
* 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
* Develop and facilitate a program that improves, drives and tracks
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 Operations.
Requirements:
* Degree qualification or equivalent (Science, Engineering, Technical)
* **Apply on the website** years**Apply on the website**; experience
in a Fill Finish/Sterile Environment / working in a GMP environment
with proven ability to drive projects and deliver results
* Operational experience within high speed aseptic filling lines and
formulations areas
* Experience in aseptic manufacturing with extensive technical
expertise in Aseptic Techniques and Form / Fill Finish.
For further information please contact Mick on (phone number removed)
or forward details in confidence to Headcount Solutions is seeking a Senior Fill / Finish Operations
Specialist for our client**Apply on the website**;s expansion
project at its biologic facility in Leinster. This senior role
requires extensive experience in aseptic fill-finish operations.
Reporting to the Associate Director of Operations, this person will be
responsible and lead operational readiness for all primary aseptic
manufacturing.
Main 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
* 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
* Develop and facilitate a program that improves, drives and tracks
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 Operations.
Requirements:
* Degree qualification or equivalent (Science, Engineering, Technical)
* **Apply on the website** years**Apply on the website**; experience
in a Fill Finish/Sterile Environment / working in a GMP environment
with proven ability to drive projects and deliver results
* Operational experience within high speed aseptic filling lines and
formulations areas
* Experience in aseptic manufacturing with extensive technical
expertise in Aseptic Techniques and Form / Fill Finish.
For further information please contact Mick on (phone number removed)
or forward details in confidence to
We need : English (Good)
Type: Permanent
Payment:
Category: Others