Manufacturing Specialist – Process Owner (Syringe)

Site Syringe Fill Finish Process Owner

Job Summary:

An exciting and rare opportunity has presented for a Site Fill Finish Process 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, Lyophilisation and Capping.   

As a Fill Finish Process 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 Fill Finish Process Lead will direct initiatives that improve the reliability and efficiency of manufacturing processes in addition to run the business support related to unplanned and/or disruptive events.  

Primary responsibilities:

• Perform as a knowledgeable subject matter expert (SME), and single point of contact on site and network projects and programs, to advance Fill Finish manufacturing operations  

• Leading and/or providing input to strategic initiatives that will improve and develop processes for the future 

• Contribute in a team environment to operational issues pertaining to processes as they arise and provide expertise and support to help resolve escalated technical issues as required 

• 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 
• Remain current on state-of-the-art for systems and processes and advise on the appropriate adoption and use of new techniques and technology 

What you need to apply:

• Bachelor’s degree in Science, Engineering or related discipline with 10 + years’ experience in the pharmaceutical industry 

• Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products. 

• Proven ability to work in a high paced matrix organization and effectively influence change and escalate issues professionally and in a timely manner 

• Excellent Decision-Making skills and confidence to respectfully and professionally challenge others on decisions that impact the manufacturing area 

• Proactive and works well with others in a collaborative, fast-paced goal-driven environment 

• Interacts well with diverse groups (Manufacturing, Validation, Engineering, Quality etc) and maintains strong working relationships with internal and external collaborators 

• Demonstrated ability to coach, mentor and/or cross train colleagues within core technical areas 

• Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (eg investigations, procedures, change controls) and good Presentation skills.