Engineer - Inspection & Packaging

Amgen; Ireland; On-site; EUR 50,000 - 61,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) is seeking an Inspection & Packaging Engineer to support the expansion of the plant's packaging and inspection capabilities on site. The role requires strong engineering knowledge across mechanical, electro-mechanical and automation systems and the ability to apply statistical analysis and CI methods.

You will own equipment performance in a GMP setting, lead root cause analyses, and drive improvements while collaborating with operations to minimise downtime and maintain

Qualifications

• Bachelor's degree in engineering (Mechanical, Manufacturing, Mechatronics, Electrical or Chemical preferred).
• Experience in medical device or pharmaceutical inspection/packaging preferred.
• Solid leadership, technical writing, and communication/presentation skills.
• Experience in change control, non-conformance, corrective and preventive actions, and validation practices.
• Ability to influence development of business area strategy and engineering/equipment strategy.

Responsibilities

• Ownership of equipment/systems in a GMP manufacturing setting.
• Monitor day-to-day performance of assigned system and perform data trend analysis.
• Lead root cause analyses and investigations for equipment-related issues.
• Develop specifications, documents and SOPs for system improvements.
• Maintain critical spare parts levels and coordinate vendor support.

Skills

Statistical analysis

Continuous improvement

Problem solving

Mechanical engineering

Automation systems

Education

Bachelor's degree in engineering

Job description

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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range

55,9