We are currently recruiting for a Process Engineer to join a global healthcare leader's Fill Finish Manufacturing site in Sligo on a temporary, 12 month contract.
Responsibilities:
As a Process Engineer you will:
1. Provide expert input on equipment commissioning and qualification related to aseptic fill-finish manufacturing.
2. Lead the design, onboarding, and qualification of single-use systems. Act as the site representative on cross-site teams to standardize assemblies and procedures.
3. Collaborate with supplier technical teams to build and maintain strong relationships.
4. Serve as the technical representative on site teams, focusing on design updates and the introduction of new single-use systems.
5. Create and align process flow diagrams for new product introductions (NPI) and technology transfers, standardizing across products.
6. Work closely with the NPI Lead to ensure smooth product transfers and implement process improvements.
7. Act as the SME for investigations, process improvements, and efficiency monitoring.
8. Write gap assessments, facility fit studies, process safety evaluations, and risk assessments for NPIs. Prepare scientific reports, technical documentation, and presentations for internal and external stakeholders.
9. Ensure all activities meet safety, regulatory, and compliance standards.
Requirements:
10. Third level degree in Chemical Engineering, Bioprocess Engineering.
11. 3-5 years' experience in biopharmaceutical industry.
12. Experience with new product introductions / technology transfers in a fill finish manufacturing facility.
13. Experience in biologics manufacturing at scale in a fill-finish facility, serving in a technical role.