Aseptic Process Lead

Summary:
An Aseptic Process Owner Lead is required for a biopharmaceutical company in South Dublin. The incumbent will continue to build on the site and network aseptic processing knowledge. This is a hybrid role.

Responsibilities:

• Perform as a knowledgeable subject matter expert (SME), and single 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 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.
• 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 conducted and actionable CAPAs, to prevent future reoccurrence, are implemented within agreed timelines.

Qualifications & Experience:

• Bachelor’s degree in Microbiology or related discipline.
• 5 + 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.
• Requires in-depth technical and operational knowledge of aseptic drug product manufacturing processes; parts/components preparation, formulation, syringe filling, vial filling, lyophilisation and capping.
• 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 (e.g. investigations, procedures, change controls) and good presentation skills.