Manufacturing Process Engineer

at  Team Horizon

Team Horizon is seeking a Manufacturing Process Engineer in Mayo for our client who are a global leader in the biopharmaceutical industry. In the role, you will have the opportunity to optimize and improve the efficiency of manufacturing processes within a multi-product aseptic environment across a wide range of process and equipment types. You will be required to ensure efficient operation of aseptic Filling lines and associated equipment. In this role you will become a ‘Subject Matter Expert’ across critical aseptic processes and will identify and lead the implementation of process improvement projects. The position will require dealing with challenging technical problems within a highly regulated environment. The successful candidate will have the ability to co-ordinate with multiple stakeholders and varying levels and areas of expertise, ensuring that the necessary skill sets for successful project delivery are available.

• Provide technical assistance to the manufacturing areas relating to the process and equipment to address issues and exceptions or support improvements.
• Develop and implement changes that will enhance equipment performance, product quality, reduce manufacturing costs and maximise efficiencies.
• Develop and modify procedures as needed to support the manufacturing areas. Submit Change plans and create investigation reports.
• Support the transfer of new products to the manufacturing area.
• Participate in process, equipment and facilities validation efforts and project implementation.
• Maintain manufacturing area equipment in compliance with site calibration and maintenance program.
• Provide support to Technical Shift Leads on batch records.
• Provide assistance and present when required at Regulatory Inspections.
• Comply with company policies and procedures and regulatory agency regulations.
• Evaluation and implement new equipment and process technology.
• Initiate capital project ideas dealing with safety, quality improvements, increases in capacity and/or cost reduction.
• Any other duties as assigned.