Manufacturing Specialist (Aseptic Process Owner)

Job Description: Manufacturing Specialist (Aseptic Process Owner)

An exciting opportunity has become available for an experienced Aseptic Process Owner to join our client’s manufacturing site in South Dublin. This key technical role is responsible for providing subject matter expertise across aseptic drug product manufacturing operations, ensuring the highest standards of safety, quality, compliance, and operational excellence.

The successful candidate will possess extensive knowledge of aseptic manufacturing processes, including component preparation, formulation, syringe and vial filling, lyophilisation, and capping. As a recognised technical expert, you will drive continuous improvement initiatives, support strategic projects, and represent the Dublin site across the company’s global manufacturing network.

This position is ideal for a proactive professional who thrives in a fast-paced environment, enjoys solving complex technical challenges, and is passionate about advancing aseptic manufacturing practices.

Key Responsibilities:

• Act as the site Subject Matter Expert (SME) for aseptic manufacturing processes, providing technical leadership across local and global projects.
• Lead and contribute to strategic initiatives focused on advancing aseptic operations, contamination control strategies, and Aseptic Process Simulations (APS).
• Provide expert technical support to manufacturing teams, helping resolve complex operational issues and ensuring minimal disruption to production.
• Stay informed of emerging technologies, industry best practices, and regulatory developments, recommending innovative solutions to enhance manufacturing performance.
• Monitor manufacturing trends, including personnel and environmental monitoring data, and use performance metrics to identify opportunities for continuous improvement.
• Participate in daily operational management activities, maintaining a clear understanding of manufacturing performance and proactively driving process optimisation.
• Lead or support technical investigations and risk assessments relating to safety, product quality, and regulatory compliance.
• Ensure investigations are thorough, scientifically justified, and result in effective corrective and preventive actions (CAPAs) that prevent recurrence.
• Collaborate closely with Manufacturing, Quality, Engineering, Validation, and other cross-functional teams to maintain robust aseptic processes.
• Represent the Dublin site within the company's global manufacturing network, sharing expertise and supporting standardisation of aseptic practices.

Skills & Experience:

• Bachelor's degree in Microbiology, Pharmaceutical Science, Biotechnology, Engineering, or a related scientific discipline.
• Minimum of five years' experience within sterile pharmaceutical manufacturing or aseptic drug product operations.
• Strong understanding of current Good Manufacturing Practice (cGMP) requirements and comprehensive knowledge of EU GMP EudraLex Volume 4, Annex 1, including practical application within sterile manufacturing.
• Demonstrated experience supporting aseptic processing operations such as formulation, sterile filling, lyophilisation, component preparation, and contamination control.
• Proven ability to work effectively within a fast-paced, cross-functional matrix organisation while influencing change and driving technical improvements.
• Sound judgement and confidence to make informed, risk-based decisions while constructively challenging decisions that may impact safety, quality, or compliance.
• Excellent problem-solving and investigation skills with experience authoring technical documentation including deviations, investigations, change controls, risk assessments, and CAPAs.
• Strong communication and presentation skills, with the ability to engage effectively with stakeholders at all levels.
• Experience coaching, mentoring, or developing colleagues within technical manufacturing environments is highly desirable.

Contract Information:

• Rate: Hourly rate dependent on level of skills and expertise.
• Start Date: ASAP.
• Contract Duration: 12 months with possibility of extension.
• Schedule: Full time.
• Onsite/Remote: Hybrid.
• Location: South Dublin