Engineer - Inspection & Packaging

Amgen; Leinster; On-site; EUR 60,000 - 90,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) is seeking an Inspection & Packaging Engineer to support expansion of plant and production capability on site. The role focuses on packaging and inspection equipment reliability across aseptic drug product operations, reporting to the Engineering Manager.

The engineer will apply statistical analysis, continuous improvement methods, and problem solving to ensure life cycle management of equipment and effective collaboration with the process teams.

Qualifications

• Bachelor’s degree in engineering (Mechanical, Manufacturing, Mechatronics, Electrical or Chemical preferred).
• Experience in manufacturing environments for medical devices or pharmaceutical inspection/packaging is desirable.

Responsibilities

• Support a safe working environment in GMP manufacturing settings.
• Own equipment/systems and monitor day-to-day performance.
• Perform data trend analysis to identify and manage performance trends.
• Lead root cause analyses and investigations for equipment issues.
• Develop and maintain maintenance schedules aligned with manufacturing needs.
• Contribute to system improvements, specifications, and SOPs.

Skills

Problem solving

Data analysis

Continuous improvement

Leadership

Education

Bachelor's degree in engineering

Tools

CAPA

Change control

Validation

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.