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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.
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