NPI Process Scientist - Biologics Process Development

Dillon Engineering Services; Connacht; On-site; EUR 70,000 - 100,000; Full time

Job summary

The NPI Process Scientist will support the introduction of new products into manufacturing, ensuring robust process development, technology transfer, and operational readiness within a cGMP environment. This role requires close collaboration with global science, quality, and manufacturing teams to deliver compliant, efficient, and high-quality processes, while adhering to EHS and regulatory standards.

You will lead and support risk assessments, transfer plans, batch records, and training of

Qualifications

• Requires third-level qualification in Engineering, Science, or a related technical discipline.
• Minimum 3 years’ experience in pharmaceutical process engineering within a cGMP environment.
• Experience in batch processing, scale-up, and technology transfer activities.
• Minimum 1 year’s experience in a similar role within pharmaceutical or biologics manufacturing.

Responsibilities

• Support development and implementation of manufacturing processes for new product introductions (NPI).
• Provide technical support for process-related issue resolution within manufacturing operations.
• Perform gap analyses, facility fit studies, and process safety and risk assessments.
• Monitor and analyse process performance data during manufacturing campaigns.
• Prepare and update specifications for NPI materials and consumables.
• Lead and/or support risk assessments (e.g. PFMEA, EHS).
• Develop NPI documentation including transfer plans, protocols, procedures, and batch records.
• Collaborate with global science and quality teams to support process development for future products.
• Support and/or lead product and process investigations and change management activities.
• Train and support operations personnel on NPI processes.
• Ensure adherence to all EHS, quality, and compliance standards.

Skills

Problem solving

Communication

Organisational skills

Attention to detail

Results oriented

Education

Bachelor's degree in Engineering, Science or related

Job description

The NPI Process Scientist will support the introduction of new products into manufacturing, ensuring robust process development, technology transfer, and operational readiness within a cGMP environment. This role requires close collaboration with global science, quality, and manufacturing teams to deliver compliant, efficient, and high-quality processes, while adhering to EHS and regulatory standards.

You will lead and support risk assessments, transfer plans, batch records, and training of