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:
- Provide expert input on equipment commissioning and qualification related to aseptic fill-finish manufacturing.
- Lead the design, onboarding, and qualification of single-use systems. Act as the site representative on cross-site teams to standardize assemblies and procedures.
- Collaborate with supplier technical teams to build and maintain strong relationships.
- Serve as the technical representative on site teams, focusing on design updates and the introduction of new single-use systems.
- Create and align process flow diagrams for new product introductions (NPI) and technology transfers, standardizing across products.
- Work closely with the NPI Lead to ensure smooth product transfers and implement process improvements.
- Act as the SME for investigations, process improvements, and efficiency monitoring.
- 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.
- Ensure all activities meet safety, regulatory, and compliance standards.
Requirements:
- Third level degree in Chemical Engineering, Bioprocess Engineering.
- 3-5 years’ experience in biopharmaceutical industry.
- Experience with new product introductions / technology transfers in a fill finish manufacturing facility.
- Experience in biologics manufacturing at scale in a fill-finish facility, serving in a technical role.
For a confidential discussion on the role and the organisation please contact Emma Barry today.
emma.barry@collinsmcnicholas.ie
091 706719