Process Engineer - API

STEM Recruitment Partners are working with an engineering consultancy company that is seeking an experienced Process Engineer to join their operations in Sligo. 12 month contract €55-65/hour DOE Job Responsibilities: The Process Engineer will leverage their comprehensive understanding of aseptic fill finish manufacturing to provide design input for equipment commissioning and qualification. The role involves the following key responsibilities: Single-Use Design and Qualification: Oversee the design, onboarding, and qualification of single-use systems. Represent the site on cross-site teams to standardize single-use assemblies and procedures. Collaborate with supplier technical teams to maintain strong relationships and act as a technical representative for site cross-functional teams, focusing on design updates and the introduction of new single-use technologies. Process Flow Diagrams (PFDs): Author PFDs for new product introductions and technology transfers. Ensure alignment and standardization of PFDs across products, working closely with the NPI Lead to meet requirements for new products or process improvements. Technical Subject Matter Expert (SME): Serve as the SME for investigations, process improvements, and process efficiency monitoring. Conduct gap assessments, facility fit studies, and process safety and risk assessments for new product introductions (NPI). Documentation and Reporting: Write scientific reports and technical documentation. Prepare presentations to communicate project status to internal and external stakeholders. Compliance and Safety: Ensure compliance with safety, regulatory, and compliance standards. Additional Duties: Perform other duties as assigned. Qualifications: Bachelor's or Master's degree in Chemical Engineering or Bioprocess Engineering. 3-5 years of experience in the biopharmaceutical industry, specifically in a technical role within a fill finish manufacturing facility. Experience with biologics and large-scale manufacturing. Proven experience with new product introductions and technology transfers in a fill finish manufacturing environment. Expertise in single-use technology and isolator technology. Familiarity with SAP and Trackwise systems. Skills: Process Engineer Chemical Engineer API