Process Engineer Sterilisation

Abbott; Kilkenny; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Family health insurance

Excellent pension scheme

Life assurance

Career development

Job summary

Abbott is seeking an experienced Process Engineer to support and optimise pharmaceutical/biological manufacturing processes in a regulated production environment. You will apply technical expertise to implement, maintain, and troubleshoot processes ensuring safe, compliant, and efficient production of high-quality products.

You will collaborate with cross‑functional teams, lead investigations using structured problem-solving methods, and drive CAPAs and change control activities while ensuring

Qualifications

• Minimum NFQ Level 7 qualification in Engineering or related field.
• Minimum 2 years’ engineering experience in a manufacturing environment.
• Experience in regulated industry and handling complex technical challenges.
• Strong communication, collaboration, and problem-solving skills.
• Electron beam, gamma or other sterilisation technologies experience desirable.
• Knowledge in ISO 11137 desirable.

Responsibilities

• Implement, maintain, and optimise pharmaceutical/biological processes in a regulated environment.
• Prepare operating procedures and technical instructions for equipment and systems.
• Monitor critical process parameters to ensure product quality.
• Investigate deviations and implement effective engineering solutions.
• Collaborate with Manufacturing, Quality, Validation, Maintenance, and Supply Chain teams.

Skills

Communication

Collaboration

Problem solving

Regulatory compliance

Education

Engineering degree (NFQ Level 7+)

Job description

About The Role

We are seeking an experienced Process Engineer to support and optimise pharmaceutical/biological manufacturing processes within a regulated production environment. Reporting into the Engineering/Operations function, you will apply your technical expertise to implement, maintain, improve, and troubleshoot manufacturing processes that ensure the safe, compliant, and efficient production of high-quality products.

Key Responsibilities

• Implement, maintain, and continuously improve pharmaceutical and biological manufacturing processes to ensure operational excellence.
• Develop, calculate, and organise process data, including process flow diagrams, equipment specifications, and instrumentation requirements.
• Model manufacturing processes and unit operations to support process optimisation and capacity improvements.
• Prepare operating procedures, process specifications, and technical instructions for manufacturing equipment and systems.
• Monitor and analyse critical process parameters such as temperature, pressure, density, viscosity, and flow rates to ensure process control and product quality.
• Investigate process deviations, performance issues, and equipment-related challenges, implementing effective engineering solutions.
• Partner with cross‑functional teams including Manufacturing, Quality, Validation, Maintenance, and Supply Chain to support production targets and continuous improvement initiatives.
• Lead or support root cause investigations using structured problem‑solving methodologies such as 5 Whys, DMAIC, Fishbone Analysis, and FMEA.
• Drive Corrective and Preventive Actions (CAPA) and ensure actions are effectively implemented and sustained.
• Support commissioning, qualification, validation, and change control activities for equipment and process improvements.
• Ensure all processes, procedures, and activities remain compliant with GMP, regulatory requirements, and company quality standards.
• Identify opportunities for cost reduction, waste elimination, yield improvement, and enhanced manufacturing efficiency.
• Generate and maintain technical documentation, reports, risk assessments, and engineering records.

Qualifications & Experience

• Minimum NFQ Level 7 qualification or higher in Engineering or a related discipline.
• Minimum of 2 years’ relevant engineering experience in a manufacturing environment, or an equivalent combination of education and experience.
• Demonstrated experience working in a regulated industry and managing complex technical challenges.
• Strong communication, collaboration, and problem‑solving skills.
• Electron beam, Gamma or other sterilisation technologies experience desirable.
• Knowledge in ISO 11137 desirable.

What We Offer

• Family health insurance.
• Excellent pension scheme.
• Life assurance.
• Career Development.
• Fantastic new facility.
• Growing business plus access to many more benefits.

Abbott is an equal opportunities employer.