Engineer - Inspection & Packaging

Amgen Inc. (IR); Ireland; Remote; EUR 56,000 - 76,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) is seeking an Inspection & Packaging Engineer to join our on-site team and support the expansion of aseptic drug product operations, including formulation, vial/syringe filling, lyophilisation, and packaging.

The role owns equipment performance in a GMP manufacturing setting, leads root-cause investigations, drives continuous improvement, and coordinates preventative maintenance with technicians.

Qualifications

• Bachelor’s degree in engineering is required.
• Experience with GMP/regulated manufacturing environments preferred.
• Strong problem-solving and analytical abilities are essential.

Responsibilities

• Owns performance of packaging and inspection equipment.
• Performs data trend analysis to identify & manage performance issues.
• Leads root-cause analyses and investigations into losses or downtime.
• Drives continuous improvement and preventative maintenance activities.
• Develops specifications, SOPs, and documentation for equipment.
• Coordinates with operations and maintenance to minimise downtime.
• Manages spare parts and supports vendor interactions.

Skills

Mechanical engineering fundamentals

Electro-mechanical systems

Automation systems

Problem solving

Education

Bachelor's degree in engineering

Tools

Statistical analysis tools

Job description

## Engineer - Inspection & PackagingApplyremote type: On Sitelocations: Ireland - Dun Laoghairetime type: Full timeposted on: Posted Todayjob requisition id: R-245560## **Career Category**Engineering## ## **Job Description**Amgen Dun Laoghaire (ADL) is looking for an Inspection & Packaging Engineer to join our Inspection & Packaging team to support the continued expansion of the plant and production capability on site. Amgen Dun Laoghaire (ADL) is a 37,000 square metre aseptic drug product operations facility, specialising in secondary manufacturing activities – Formulation, Vial/Syringe Filling, Lyophilisation and Packaging.This position will be responsible for performance of packaging & inspection equipment on site. The engineer will report to the Engineering Manager and should have knowledge and proficiency 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. The engineer will also have full overall responsibility for the reliability and life cycle of equipment.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.* Data trend analysis of all performance aspects of their system and equipment to identify and proactively manage performance trends.* Responsible for updating and communicating with the operations team, in a responsive manner to ensure they are kept informed on all engineering activities / investigations / reports on losses etc...* Proactively identify opportunities for improvement in equipment & processes as well as Preventative maintenance support to technicians for regular activities.* Support system improvements, development of detailed specifications, engineering documents and standard operating procedures.* Create and maintain a structured and target driven annual maintenance schedule which will align with the manufacturing schedule to minimise downtime. This includes long term planning for vendor support on site and the procurement of major spare part assemblies well in advance.* Lead technical root cause analysis, incident investigations and after-action reviews when troubleshooting issues related to manufacturing equipment/systems.* Working in a collaborative manner within the Process Teams structure and contributes to investigations, Non-Conformance and CAPA closure.* Ensuring that a critical spare parts list for their system is identified and appropriate levels of spares are maintained.* Willing to adapt and to take responsibility for other equipment outside of immediate responsibility to support the wider group when resources are stretched.* 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, Manufacturing, Mechatronics, Electrical or Chemical preferred).Preferred Qualifications:* Manufacturing experience in medical device or pharmaceutical inspection or packaging.* Solid leadership, technical writing, and communication/presentation skills* Experience in change control, non-conformance, corrective and preventative actions, and validation practices* Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate* Day to day vendor management and contract negotiations with focus on equipment suppliers* 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..**Salary Range**55,960.60 EUR - 75,711.40 EUR