Engineer - Inspection & Packaging

Role Overview

Amgen Dun Laoghaire (ADL), a 37,000 sq metre aseptic drug product operations facility specializing in secondary manufacturing—such as Formulation, Vial/Syringe Filling, Lyophilisation, and Packaging—is seeking an Engineer for Inspection & Packaging. This role supports the ongoing expansion of the plant and its production capabilities.

The engineer will oversee the performance and lifecycle of packaging and inspection equipment onsite, reporting to the Engineering Manager. Expertise in statistical analysis, continuous improvement, problem solving, and applied engineering related to mechanical, electro-mechanical, and automation systems is essential.

Key Responsibilities

• Ensure a safe work environment by adhering to all relevant EHS policies, rules, and regulations.
• Take ownership of equipment and systems operating under GMP-regulated manufacturing conditions.
• Supervise day-to-day performance of assigned systems.
• Analyze data trends to track equipment/system performance and proactively address issues.
• Communicate effectively with operations teams regarding engineering activities, investigations, and loss reports.
• Identify opportunities to enhance equipment, processes, and support preventative maintenance activities.
• Contribute to system improvements, including developing detailed specifications, engineering documentation, and SOPs.
• Develop and maintain a targeted annual maintenance schedule aligned with manufacturing to minimize downtime, including long-term planning for vendor support and spare parts procurement.
• Lead root cause analyses, incident investigations, and after-action reviews to troubleshoot manufacturing equipment issues.
• Collaborate within Process Teams to support investigations, Non-Conformance, and CAPA closure.
• Maintain a critical spare parts inventory at appropriate levels.
• Adapt and take responsibility for additional equipment as needed to support the group during resource constraints.
• Facilitate new product or technology introductions through engineering assessments, system change implementations, and engineering runs.

Basic Qualifications

• Bachelor’s degree in engineering disciplines such as Mechanical, Manufacturing, Mechatronics, Electrical, or Chemical.

Preferred Qualifications

• Experience in manufacturing medical devices or pharmaceutical inspection/packaging environments.
• Strong leadership, technical writing, communication, and presentation capabilities.
• Expertise in change control, non-conformance handling, corrective and preventative action (CAPA), and validation procedures.
• Capability to influence business and engineering strategy development.
• Experience negotiating contracts and managing vendors, especially equipment suppliers.
• Self-driven, well-organized, independent, and adept at multitasking in production settings.
• Collaborative team player willing to support broader business needs in a team-oriented culture.