Manufacturing Specialist – Manufacturing Process Owner Lead
Job Summary:
An exciting and rare opportunity has presented for a Process Owner Lead at Amgen, Dublin. This is a senior role in the organisation and requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling.
As a Process Owner Lead you will be an established professional who is a self-starter, capable of applying advanced process knowledge and creativity to complete complex assignments related to the manufacturing operations. You are someone who contributes to the development of new principles and concepts, who wants to be challenged and can lead change from a manufacturing operations perspective.
Supporting key areas of the business, the Process Owner Lead will direct initiatives that improve the reliability and efficiency of manufacturing processes in addition to day-to-day support related to unplanned event troubleshooting, investigations, CAPA identification and implementation.
Primary responsibilities:
Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance manufacturing and aseptic operations through ownership of the assigned processes and taking a proactive approach to safety, quality, and compliance by actively seek opportunities to remove error traps.
Accountable for process documentation (e.g., SOPs, Training, Electronic Batch Records, Risk Assessments) in assigned area of responsibility. Gatekeeper (develop, review and update) of process documentation to maintain structure and control over generation and revision ensuring the documents clearly and correctly direct the process.
Utilise subject matter expertise to identify and lead continuous improvement projects in assigned area of responsibility. Ensure project timelines are met, challenges identified, mitigations are in place and communication plans delivered to all stakeholders.
Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends including business performance metrics. Identify actions that will enable the process and the Manufacturing areas better achieve and surpass metrics in the future.
Lead and/or Support investigations that impact on safety, quality and/or compliance of the processes, ensuring thorough investigations are carried out and actionable CAPAs, to prevent future reoccurrence, are identified and implemented within agreed timeline.
What you need to apply:
Interacts well with diverse groups (Manufacturing, Validation, Engineering, Quality etc) and maintains strong working relationships with internal and external collaborators.
Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (e.g., investigations, procedures, change controls) and good Presentation skills.