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Details

Aseptic Process Lead


Reference:JSC00032008 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Process Engineer

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

An exciting and rare opportunity has presented for the Aseptic Process Lead for the New Vial Filling Line coming. 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.
The Aseptic Process Lead will continue to build on the site and network aseptic processing knowledge and represent the Dublin site at a global level across the Amgen manufacturing network.
As the Site Aseptic 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 aseptic operations. You are someone who contributes to the development of new principles and concepts, who wants to be challenged and can lead change from an aseptic operations perspective.
• Perform as a knowledgeable subject matter expert (SME), and single point of contact for the new vial line project to deliver aseptic operations.
• Leading strategic initiatives for the new vial filling project, that will provide future benefit to manufacturing including Contamination Control and Aseptic Process Simulations (APS).
• Contribute in a team environment to operational issues pertaining to processes as they arise across the vial line project and provide expertise and support to help resolve escalated technical issues as required.
• Remain current on state-of-the-art for systems and processes and advise on the appropriate adoption and use of new techniques and technology.
• 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 (Personnel and Environmental Monitoring), 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 timelines.

Education & Experience

• Bachelor’s degree in Microbiology 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 challenge others respectfully and professionally 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.