Senior Equipment Engineer - Packaging System Owner

Amgen Inc. (IR); Dublin; On-site; EUR 70,000 - 95,000; Full time

Job summary

Amgen Dun Laoghaire (ADL) seeks a Senior Packaging Engineer to join the Inspection & Packaging Engineering team. You will drive enhancements to manufacturing processes, equipment and products, lead technical projects, and collaborate across functions to advance innovation and efficiency on site.

The role requires hands-on experience with automation systems, problem solving and statistical analysis tools, and a track record in packaging/inspection within pharma or medtech environments.

Qualifications

• Bachelor's degree in engineering (Mechanical, Electrical or Mechatronic preferred).
• Demonstrated solid leadership with ability to build teams and operate across functional boundaries.
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Experience in vendor management and contract negotiations with focus on equipment suppliers and SLAs.
• Significant experience with GMP qualification activities.

Responsibilities

• Support a safe working environment by complying with EH&S practices and regulations.
• Own equipment/systems in a GMP manufacturing setting.
• Monitor day-to-day performance of assigned systems and equipment.
• Regularly report performance and issue resolution plans for packaging equipment.
• Lead root cause analysis, incident investigations and troubleshooting for equipment/systems.
• Collaborate with Process & Quality teams on investigations and CAPA closure.
• Support project teams with equipment upgrades, FAT/SAT/IOQ protocols.
• Identify critical spare parts and maintain appropriate spare levels.
• Plan future improvements and downtime for equipment.
• Support new product introductions and evaluate system changes.

Skills

Leadership

Change control

Vendor management

GMP qualification

Automation

Packaging equipment

Project management

Cross-functional collaboration

Statistical analysis tools

Education

Bachelor's degree in engineering (Mechanical/Electrical/Mechatronic)

Tools

Statistical analysis tools

Job description

Career Category Engineering Job Description

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 .

Salary Range 70,408.90 EUR - 95,259.10 EUR

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen