Amgen
Pharmaceutical
SeniorEquipmentEngineerPackagingSystemOwner
“Senior Equipment Engineer - Packaging System Owner at Amgen. Skills: Packaging System Owner, Inspection & Packaging Engineering, manufacturing processes, equipment, products, technical projects, automation systems. Support a safe working environment. Ownership of equipment/systems in a GMP regulated manufacturing setting.”
What You'll Achieve.
drive innovation and efficiency; ensure changes are fit for purpose and meet business needs.
Industry & Context.
solve complex problems; problem solving; Anticipating, solving or escalating problems; Data trend analysis; identify and proactively manage performance trends.; technical root cause analysis; incident investigations; troubleshooting issues
Travel at various times may be required to support execution of projects.
What They're Looking For.
Must Have
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.
Nice to Have
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., 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.
What You'll Do.
Support a safe working environment
Ownership of equipment/systems in a GMP regulated manufacturing setting.
Monitoring of day-to-day performance of their assigned system.
report out on performance and issue resolution plans for all packaging equipment.
solving or escalating problems
Data trend analysis of all performance aspects of their system and equipment
identify and proactively manage performance trends.
Proactively identify opportunities for continuous improvement in equipment & processes
preventative maintenance support
Anticipate issues and plan effective preventative solutions
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
Lead technical root cause analysis
incident investigations and troubleshooting issues related to manufacturing equipment/systems
follow up to ensure learnings are actioned.
Provide oversight & support the Project Team with equipment upgrades and new equipment introductions
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
How You'll Work.
Team & Collaboration
collaborate with cross-functional teams; Collaborate & support the Process & Quality Team in investigations, Non-Conformance and CAPA closure.; support the Project Team with equipment upgrades and new equipment introductions; support other areas to meet business requirements.
Communication Scope
report out on performance; issue resolution plans
Process & Methodology
lead technical projects, large project related activities, equipment upgrades, new equipment introductions
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