Title: Aseptic Operations Engineer
Location: Sligo, Ireland
Type: Contract – 12 Months
Salary: €40 - €50 per hour
Overview
We are currently recruiting for an Aseptic Operations Engineer to join a leading biologics manufacturing environment in Sligo. This role will support the continued development and optimisation of aseptic manufacturing operations by acting as a technical subject matter expert across equipment, cleanroom, and utility systems.
The successful candidate will play a key role in ensuring aseptic manufacturing systems operate in line with GMP requirements, contamination control strategy, and industry best practice while driving continuous improvement initiatives across sterile operations.
This opportunity is ideal for an engineer with strong hands‑on aseptic manufacturing experience and exposure to sterile equipment, cleanroom operations, and regulatory environments.
Responsibilities
Act as the technical SME for equipment, cleanroom, and utility systems supporting aseptic manufacturing.
Ensure aseptic manufacturing systems remain compliant with GMP, safety, environmental, and regulatory requirements.
Support existing engineering and manufacturing systems to ensure performance aligns with design intent.
Monitor and assess:
Cleanroom environmental conditions (temperature, humidity, airflow, differential pressure)
Utility system performance
Critical aseptic equipment cycles including CIP, SIP, VHP, autoclaves, aseptic filling, depyrogenation, lyophilisation, and sterilisation processes.
Investigate and troubleshoot equipment, utility, and process‑related events.
Support root cause investigations and implementation of effective CAPAs.
Drive contamination control and sterility assurance initiatives across manufacturing operations.
Partner with Engineering, Manufacturing, Quality, Microbiology, and Sterility teams to ensure safe and compliant batch execution.
Lead and support continuous improvement projects related to aseptic operations and engineering systems.
Support process validation, equipment qualification, and system optimisation activities.
Ensure engineering changes are managed through established change control procedures.
Apply risk management tools including FMEA and hazard assessment methodologies.
Support regulatory inspections and audit readiness activities.
Contribute to contamination control strategy and aseptic process improvement initiatives.
Requirements
Essential
Third‑level qualification in Engineering or equivalent discipline.
Minimum 3 years’ experience within a GMP manufacturing environment.
Minimum 1 year supporting aseptic manufacturing operations.
Strong understanding of sterile manufacturing principles and aseptic processes.
Experience working within regulated pharmaceutical or biologics environments.
Excellent communication and stakeholder management skills.
Desirable
Experience with isolator and RABS technology.Knowledge of EMA Annex 1 and FDA sterile manufacturing guidelines.
Hands‑on experience with:
Sterile equipment operation and troubleshooting
Cleanroom environmental controls
HVAC and utility systems
Equipment qualification and validation
Contamination control strategies
Previous exposure to regulatory inspections and audit support.
Project management experience with end‑to‑end delivery responsibility.
Experience driving continuous improvement and operational excellence initiatives.
Please note
Only candidates with a valid work visa for Ireland or an EU passport will be considered.
For more information, contact Corné – 0949316002 corne@dillones.ie
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