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Amgen Dun Laoghaire (ADL) is looking for a Senior Packaging Engineer to join our Inspection & Packaging Engineering team to support the continued expansion of the plant and production capability on site. The Senior Engineer at Amgen is responsible for developing and improving manufacturing processes, equipment, and products. They apply their engineering expertise to solve complex problems, lead technical projects, and collaborate with cross-functional teams to drive innovation and efficiency within the company. The engineer will report to the Engineering Manager and should be proficient in the use of statistical analysis tools, continuous improvement methodologies, problem solving and applied engineering skills relating to mechanical, electro-mechanical and associated automation systems. Previous experience in installation, servicing and maintenance of Inspection & packaging equipment would be a distinct advantage. The engineer will also have full overall responsibility for the reliability and life cycle of equipment and previous hands-on experience in resolving automation system issues would be a distinct advantage.
Job Responsibility:
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Ownership of equipment/systems in a GMP regulated manufacturing setting
Monitoring of day-to-day performance of their assigned system
Data trend analysis of all performance aspects of their system and equipment
Proactively identify opportunities for continuous improvement in equipment & processes as well as preventative maintenance support
Anticipate issues and plan effective preventative solutions
Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures
Ownership of all GMP documentation and their accuracy throughout the lifetime of the equipment
Lead technical root cause analysis, incident investigations and troubleshooting
Collaborate & support the Process & Quality Team in investigations, Non-Conformance and CAPA closure
Provide oversight & support the Project Team with equipment upgrades and new equipment introductions
Ensuring that a critical spare parts list for their system is identified and appropriate levels of spares are maintained
Maintain a structured plan for future improvements and downtime for equipment
Support new product introductions or new technology introductions
Requirements:
Bachelor's degree in engineering (Mechanical, Electrical or Mechatronic preferred)
Senior level experience of providing technical solutions in the packaging, inspection, medical device or pharmaceutical sector
Demonstrated solid leadership, with the ability to build teams and operate across functional boundaries, both internal and external
Experience in change control, non-conformance, corrective and preventative actions, and validation practices
Demonstrated experience of vendor management and contract negotiations with focus on equipment suppliers, SLA's and continuous supplier performance
Significant experience large project related activities including GMP qualification experience
Nice to have:
Typically, 5+ years’ engineering experience in an automated packaging or inspection of pharmaceutical, combination products or medical device product environment
Experience supporting packaging lines essential
Automation/ serialisation and vision system experience an advantage
Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous
Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate
Independent, self-motivated, organized, able to multi-task in a production environment
Team player, prepared to work in and embrace a team-based culture that relies on collaboration, support other areas to meet business requirements