Mechanical Engineer
تفاصيل الوظيفة
Cork: +353 21 4509200 | Dublin: +353 1 5175910 Our client is a leading biopharmaceutical company dedicated to improving the lives of patients through innovative and life-saving therapies. Their Cork facility plays a crucial role in manufacturing and distributing these life-saving products to patients worldwide. We are seeking a highly motivated and experienced Mechanical Engineer to join their team and help them continue their mission of delivering high-quality biopharmaceutical products. Position Summary: The successful candidate will be responsible for Mechanical safety in the design and life cycle of all mechanical installations and equipment. This role supports and maintains current design documentation and is responsible to ensure that all modifications to the site and mechanical equipment are in accordance with relevant standards, specifications, and regulatory requirements. Key Responsibilities:
- Design, develop, and optimize mechanical systems and equipment used in pharmaceutical manufacturing processes, such as reactors, fermenters, filtration systems, and packaging machinery.
- Collaborate with cross-functional teams including process engineers, biologists, chemists, and regulatory experts to ensure mechanical designs meet process requirements and regulatory standards.
- Perform regular maintenance, troubleshooting, and repair of mechanical equipment to ensure uninterrupted manufacturing operations.
- Conduct root cause analysis and implement corrective and preventive actions to address equipment failures and deviations.
- Implement predictive maintenance strategies utilizing condition monitoring techniques to minimize downtime and optimize equipment performance.
- Ensure all mechanical systems and equipment comply with relevant regulatory requirements such as FDA cGMP (Current Good Manufacturing Practices), EH&S (Environment, Health, and Safety), and international standards.
- Identify opportunities for process improvement, cost reduction, and efficiency enhancement through the application of innovative mechanical engineering solutions.
- Relevant Mechanical Engineering qualification.
- 12+ years experience in the Pharma/Biopharma industry or a GMP environment
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