Aseptic Manufacturing Engineering Specialist

Aseptic Manufacturing Engineering Specialist

About the Role

We are seeking an experienced Aseptic Manufacturing Engineering Specialist to support and enhance aseptic manufacturing operations within a GMP-regulated environment.

This role will act as a Subject Matter Expert (SME) for aseptic manufacturing equipment, cleanroom, and utility systems, ensuring they are designed, operated, and maintained in compliance with regulatory requirements and industry best practices. The successful candidate will partner closely with Engineering, Operations, Quality, and Automation teams to ensure the highest standards of sterility assurance, safety, and operational performance.

Key Responsibilities

• Act as the SME for aseptic manufacturing equipment, cleanrooms, and utility systems.

• Ensure compliance with GMP, aseptic manufacturing regulations, and applicable safety and environmental standards.

• Monitor aseptic manufacturing systems in real time, including:

  • Cleanroom performance (temperature, humidity, differential pressure, airflow).

  • Utility systems supporting aseptic operations.

  • Critical equipment cycles such as CIP/SIP, VHP, aseptic filling, autoclaves, lyophilisation, depyrogenation, and bulk heat sterilisation.

• Investigate and respond to automation and system alarms, ensuring appropriate alarm prioritisation and resolution.

• Trend system performance data and develop action plans to address deviations or opportunities for improvement.

• Support manufacturing operations to ensure safe, compliant, and timely batch execution while maintaining sterility assurance.

• Participate in troubleshooting and investigations related to equipment, cleanroom, or utility deviations.

• Support investigations into sterility, media fills, environmental monitoring excursions, and EMPQ activities, contributing to root cause analysis and CAPA development.

• Drive continuous improvement of aseptic manufacturing engineering systems and procedures.

• Provide engineering input into the design, modification, and optimisation of aseptic manufacturing equipment and facilities.

• Lead or support engineering projects related to equipment, cleanroom, and utility system changes.

• Ensure preventive maintenance strategies are appropriate and effective for aseptic systems.

• Ensure all engineering changes follow change control and risk management processes.

• Support regulatory inspections and audits as an aseptic engineering SME.

• Contribute to the development and maintenance of site contamination control and sterility assurance strategies.

• Promote a strong quality culture, high performance standards, and an environment that encourages speaking up.

Qualifications & Experience

• Third-level qualification in Engineering (e.g. Process, Chemical, Biochemical, Mechanical, Electrical, Automation, or related discipline).

• 3+ years' experience in a GMP-regulated manufacturing environment.

• At least 1 year's experience supporting aseptic manufacturing or sterile operations.

• Strong understanding of aseptic processing and sterility assurance principles.

• Experience working with cleanrooms, utilities, and automated manufacturing systems.

• Demonstrated experience in investigations, root cause analysis, and CAPA.

• Project experience within a regulated manufacturing environment.

• Excellent communication skills with the ability to work cross-functionally.

Desirable Experience

• Experience in fill-finish, biologics, or sterile pharmaceutical manufacturing.

• Familiarity with automation platforms (e.g. PLC/SCADA/DCS).

• Experience supporting regulatory inspections (HPRA, FDA, EMA, etc.).