Equipment Process Engineer

Capping System Owner Equipment Engineer – Fill-Finish

Amgen Dun Laoghaire (ADL) is looking for a Capping System Owner Equipment Engineer to join the Equipment Engineering team. This role will support the continued expansion of the site and ensure the reliable, compliant, and efficient operation of capping equipment used in the manufacture of sterile drug product.

The successful candidate will be the technical system owner for assigned capping equipment and associated systems. They will be responsible for equipment reliability, lifecycle management, technical performance and continuous improvement, while ensuring equipment consistently meets requirements for product quality, patient safety and GMP compliance.

The engineer will report to the Principal Engineer, Vial Equipment Engineering, and will use mechanical, automation and applied engineering expertise to solve complex problems, support technical projects and collaborate with Manufacturing, Maintenance, Quality, Process Development, Automation, Validation and external equipment suppliers. Experience supporting capping systems within an aseptic or sterile fill-finish manufacturing environment is highly desirable.

Responsibilities

• Support a safe working environment by complying with all applicable environmental, health, safety, quality and GMP requirements.
• Act as the technical system owner for assigned capping equipment and associated systems in a GMP-regulated fill-finish manufacturing environment.
• Take ownership of equipment reliability, availability, performance, lifecycle planning and continuous improvement activities.
• Monitor day-to-day performance of assigned systems, including equipment uptime, output, reject rates, stopper and cap placement, container handling and recurring fault trends.
• Use data trend analysis to identify and proactively manage equipment performance risks, quality risks and emerging reliability issues.
• Support technical troubleshooting, root cause analysis and investigation activities for equipment failures, process interruptions, deviations and recurring manufacturing issues.
• Collaborate with Manufacturing, Quality, Maintenance, Process, Automation and Validation teams to investigate non-conformances and implement effective CAPAs.
• Support equipment improvements, including upgrades to capping heads, cap-feeding and orientation systems, reject mechanisms, container handling, controls and associated inspection or verification technologies.
• Develop and maintain engineering specifications, risk assessments, user requirement specifications, functional design specifications, standard operating procedures, maintenance strategies and other GMP documentation required throughout the equipment lifecycle.
• Support change control activities, ensuring equipment modifications are appropriately assessed, documented, implemented and qualified.
• Provide technical support to Maintenance teams for preventative maintenance, troubleshooting, equipment setup, fault finding, repair and optimisation activities.
• Develop and maintain a critical-spare-parts strategy, ensuring appropriate inventory levels, supplier support and obsolescence plans are in place.
• Maintain a structured equipment lifecycle and improvement plan, including planned downtime activities, reliability projects, capacity improvements and capital investment opportunities.
• Support equipment upgrades and new equipment introductions, including vendor design reviews, FAT, SAT, commissioning, engineering runs and IOQ activities.
• Work closely with external equipment suppliers to resolve technical issues, manage vendor performance and ensure equipment designs and modifications meet site and business requirements.
• Support new product introductions, technology transfers and engineering studies by assessing equipment capability, implementing required system changes and supporting manufacturing campaigns.

Basic Qualifications

• Bachelor’s degree in Engineering, preferably Mechanical, Electrical, Mechatronic, Automation or a related discipline.
• Greater than 2 years’ relevant engineering experience in pharmaceutical, biotechnology, medical-device or another highly regulated manufacturing environment.
• Demonstrated experience in equipment ownership, reliability engineering, lifecycle management, technical troubleshooting and continuous improvement.
• Strong mechanical and electro-mechanical engineering capability, with practical experience resolving equipment issues in a manufacturing environment.
• Experience in change control, deviations/non-conformances, CAPAs, risk assessments, validation and qualification practices.
• Strong communication and collaboration skills, with the ability to work effectively across functional teams and with external suppliers.
• Demonstrated ability to support and deliver technical projects while managing competing priorities in a fast-paced manufacturing environment.

Preferred Qualifications

• Greater than 4 years’ engineering experience in sterile manufacturing, fill-finish, aseptic processing, pharmaceutical, biotechnology or medical-device manufacturing.
• Direct experience supporting capping equipment, including cap feeding, cap orientation, rotary or inline cappers, crimping, container handling, reject systems and associated controls.
• Experience with vial, syringe or cartridge filling operations and an understanding of critical quality attributes associated with container-closure systems.
• Experience working in an aseptic manufacturing environment, including knowledge of contamination-control principles and the impact of equipment performance on product quality and sterility assurance.
• Experience with automated manufacturing equipment, PLC-controlled systems, servo systems, robotics, vision systems, SCADA or manufacturing data systems.
• Experience supporting FAT, SAT, commissioning, qualification and validation activities for new or modified equipment.
• Experience with vendor management, service-level agreements, spare-parts management and supplier-performance improvement.
• Familiarity with statistical analysis tools, structured problem solving and continuous-improvement methodologies.
• Independent, self-motivated, organised and able to manage multiple priorities in a production environment.
• Team player, prepared to work in and embrace a team-based culture that relies on collaboration and supports other areas to meet business requirements.

Travel at various times may be required to support vendor activities, equipment factory acceptance testing and project execution.