GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client's needs. We have multiple projects that we support, and we are looking to add to our team, we are interested in talking to you if you fit the criteria outlined below: Process Engineer - Fill Finish Job Dept: Technical Operations Reports to: NPI Technical Manager Responsibilities Process Engineer for Fill Finish Manufacturing site Leverage detailed understanding of aseptic fill finish manufacturing for design input into equipment commissioning and qualification. Responsible for single use design, onboarding, and qualification. Act as site representative on cross-site teams for standardization of single use assemblies and procedures. Work with supplier technical teams to maintain good relationship. Technical representative on site cross-functional team for design updates and introduction of new single use to site. Author of process flow diagrams for new product introductions / technology transfers. Responsible for aligning PFD between products and standardizing for NPI. Aligns with NPI Lead for product transfer on requirements for new products or process improvements. Technical SME for investigations, responsible for process improvements and monitoring of process efficiency. Author gap assessments, facility fit studies, process safety and risk assessments for NPI. Author scientific reports and technical documentation and presentations to document and communicate project status to internal and external stakeholders. Understand and ensure compliance with safety, regulatory and compliance expectations. Other duties as assigned. Education & Key Requirements Third level degree in Chemical Engineering, Bioprocess Engineering 3-5 years' experience in biopharmaceutical industry. Biologics experience with at scale manufacturing in fill finish facility in a technical role. Experience with new product introductions / technology transfers to fill finish manufacturing facility. Experience in single use technology Experience in isolator technology Experience in SAP / Trackwise We offer competitive compensation packages and opportunities for professional growth in a dynamic and innovative work environment. If you are a motivated Process Engineer seeking an exciting challenge in the biopharmaceutical industry, we encourage you to apply. To start the process click the Continue to Application or Login/Register to apply button below.
