Job Description
Shift Process Engineer 11 month contract On site - Carlow AMC21873 We are looking for several Shift Process Engineers for an expanding biotechnology client based in Carlow. In this role you will be responsible for providing process, technical, and validation support to operations for commercial manufacturing and Process Simulation development and execution. Accountable for all studies associated with the development of new components, products, processes systems and facilities in relation to process simulations. This is the perfect role for a Graduate with 1-2 years of GMP industry experience in aseptic manufacturing. In this role, you will: Design, author, review, approve, and execute process simulation studies to support both new product launches and ongoing manufacturing activities. Provide technical input by authoring, reviewing, or approving process simulation-related investigations as part of quality notifications. Oversee the qualification and validation of commercial and process simulation studies, ensuring alignment with standard approval processes. Analyze data to make informed decisions and recommendations based on findings. Support continuous improvement initiatives through Lean Six Sigma methodologies. Lead and participate in projects, system failure investigations, and the preparation of investigation reports. Develop and execute change controls to enhance the process simulation workflow. Contribute to Kaizen events and other process improvement initiatives. Conduct root cause analysis for system failures or performance issues, utilizing tools such as FMEA, Fishbone diagrams, and 5 Whys. Implement corrective actions via the change management system. Serve as the technical representative in internal and global discussions related to process simulations. Collaborate with cross-functional teams and liaise with external vendors or global teams as needed. Ensure adherence to Policies, Procedures, and Guidelines, as well as regulatory and cGMP (current Good Manufacturing Practices) requirements. Maintain accountability for compliance through risk assessments, corrective actions, audit participation, and proactive issue identification. Promote a safe and compliant work culture within the facility. Requirements: Experience in a Aseptic sterile manufacturing environment preferred Demonstrated ability to coach and lead change Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment Bachelors degree in science, engineering or other technical disicpine For more information get in touch with Angela McCauley or apply today! Skills: Process Engineer Lean six sigma Process improvement