Career Category
Engineering
Job Description
Amgen Dun Laoghaire (ADL) is looking for a Senior Engineer to join our Inspection Engineering 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 Inspection.
This position will be responsible for the performance and introduction of new syringe inspection equipment on site. The Sr. Engineer will take ownership of a system(s) and will be seen as a subject matter expert and contact person for any process or technical related requirements of said equipment. 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.
- 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.
- Designing, executing, implementing and directing engineering or process projects which significantly contribute to attaining high system performance.
- Working in a collaborative manner within the Process Teams structure and contributes to investigations, Non-Conformance and CAPA closure.
- Development of FAT, SAT, IOQ and other testing documents and ensuring that any activities on the equipment is acceptable to achieve GMP & business goals.
- 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 medical device, pharmaceutical inspection or medical packaging sectors.
- 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 inspection of pharmaceutical, combination products or medical device product environment.
- Experience supporting highly automated and high-speed equipment lines essential. Automation and vision system experience an advantage
- Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate
- Experience of building dashboards and using AI (specifically machine learning) to present real time performance and to create tools which can identify possible future events ahead of occurrence.
- 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
.