Manufacturing Specialist - Aseptic Process Owner

Manufacturing Specialist - Aseptic Process Owner
Hybrid
RK5543
Contract 12 months
Dublin



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.



This role in the organisation requires in-depth technical and operational knowledge of aseptic Drug Product manufacturing processes; Parts/Components Preparation, Formulation, Syringe Filling, Vial Filling, Lyophilisation and Capping.





Key Responsibilities:

• Perform as a knowledgeable subject matter expert (SME), and point of contact on site and network projects and programs, to advance aseptic operations
• Leading and/or providing input to strategic initiatives that will improve and develop Manufacturing processes for the future including Contamination Control and Aseptic Process Simulations (APS)
• Contribute to 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
• Remain current on state-of-the-art 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/ risk-based decisions 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

• Bachelor’s degree in Microbiology or related discipline
• 5 + years’ experience in the sterile pharmaceutical industry
• Experience with regulatory compliance in cGMP manufacturing and in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of Sterile Medicinal Products and its interpretation.
• Strong Technical writing skills for cGxP documentation (eg investigations, procedures, change controls) and good Presentation skills.