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
Apply on Linkedin
