Manufacturing Specialist - Manufacturing Process Owner

Manufacturing Specialist - Manufacturing Process Owner

Amgen

Dublin, Ireland

Job Summary:

The Manufacturing Process Owner role is a Senior role in a newly forming team requiring in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling and Lyophilisation, Capping. Supporting key areas of the business, the Manufacturing Process Owner 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:

• Supporting manufacturing in delivering supply to patients through Ownership of the assigned processes and taking a proactive approach to safety, quality and compliance by actively seek opportunities to remove error traps;
• Subject Matter Expert with thorough in-depth knowledge of the assigned aseptic end to end processes and interfaces, ensuring audit and inspection readiness and presenting on manufacturing processes during facility tours and inspection requests;
• Accountable for process documentation (eg 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;
• 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 timelines;
• Ownership and project management, within agreed timelines, of CAPAs and Change Controls;
• Utilises subject matter expertise to identify and lead continuous improvement projects in assigned area of responsibility. Ensuring project timelines are met, challenges identified, mitigations are in place and communication plans delivered to all stakeholders;
• Engaging with staff members within the Manufacturing to ensure understanding of the processes and working collaboratively cross functionally with Facilities & Engineering, Quality, PD and Supply Chain;
• 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;
• Provide technical input to the shift teams on challenges that are encountered. Actively looking at ways to assist in the running of the business and provide support to actions that are related to assigned area of responsibility;
• Providing expertise to Project Teams responsible for the introduction of new products and projects, ensuring successful implementation in the manufacturing area;
• Effectively engaging and participating within a Lean culture environment where continuous improvement behaviours are expected, and programs are employed. The role will require incorporation of Lean concepts into assigned project(s). Managing and implementing projects that develop lean practices in the manufacturing areas.

Competencies/Skills:

• Problem solving skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity;
• Project Management and organizational skills, including ability to follow assignments through to completion;
• Demonstrated ability to work independently and deliver right first-time results under minimal direction;
• Escalate issues professionally and in a timely manner;
• Negotiation and Influencing skills;
• Take initiative to identify and drive improvements using lean six sigma tools;
• Excellent verbal and written communication skills: Strong Technical writing skills for cGxP documentation (e.g. investigations, procedures, change controls) and good Presentation skills;
• Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area;
• Teamwork and ability to coach, mentor and/or cross train colleagues within core technical areas;
• Ensures compliance within regulatory environment;
• Familiar with data analytics.

Education and Relevant Experience:

• Minimally Bachelor Science, Engineering or technical discipline;
• 10+ years of manufacturing experience in aseptic Drug Product Manufacturing or related cGxP manufacturing experience;
• Experience with regulatory compliance in cGxP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products.

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