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.).