Job Reference: JO-2004-65110_1590067871
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.
- 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
- 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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