Process Scientist

The successful candidate will work closely with cross-functional site teams and global science and quality functions on the development, qualification, and lifecycle management of single use materials within the product path for biologics manufacturing.

• Collaborate with site and global teams to develop and evolve single use materials used in biologics manufacturing.
• Ensure compliance with all EHS&E standards and policies.
• Provide technical support to operations; lead investigations and design experiments for troubleshooting or validation.
• Monitor and analyse process data during manufacturing campaigns.
• Serve as the technical lead for vendor and manufacturer interactions, including validation package review and complaint resolution.
• Support, supervise, and train operations personnel in single use processes.
• Create and maintain specifications for new product introduction (NPI) materials and consumables.
• Lead or support risk assessments for new or modified product paths, including single use materials (e.g., pFMEA, Extractables & Leachables assessments), and manage associated change activities.
• Contribute to development of manufacturing processes for new products, including drafting and reviewing protocols, procedures, and batch records.

**Only candidates with a valid work visa for Ireland or an EU passport will be considered.

• Bachelor’s degree in science, engineering, or related technical discipline.
• At least 1 year experience in design, onboarding, and qualification of single use assemblies.
• Experience working with external vendors and global stakeholders in a client-facing capacity.
• Minimum 2 years’ experience in biologics manufacturing using single use systems in a GMP environment.

Salary: Competitive Package