Job Description

Career Category

Engineering

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.

Key Responsibilities

• 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. Expected to regularly report out on performance and issue resolution plans for all packaging equipment. Anticipating, solving or escalating problems as appropriate.

• Data trend analysis of all performance aspects of their system and equipment to identify and proactively manage performance trends.
• Proactively identify opportunities for continuous improvement in equipment & processes as well as preventative maintenance support to technicians for regular activities.
• Anticipate issues and plan effective preventative solutions in a timely matter and plan works around a busy manufacturing schedule and defined available resources.
• 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 (e.g. Risk assessments, Functional Design, User Requirement specifications etc.)
• Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems and follow up to ensure learnings are actioned.
• 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, including FAT, SAT & IOQ protocols to ensure changes are fit for purpose and meet business needs.
• 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 by performing engineering assessments, implementation of system changes and supporting engineering runs.

Basic Qualifications:

• 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.

Preferred Experience:

• 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.

Travel at various times may be required to support execution of projects