Shutdown & Non-Commercial Time Co-Ordinator
Amgen
The F&E Shutdown & Non-Commercial Time Co-ordinator is responsible for the planning, execution and delivery of all engineering shutdown/slowdown activities within the plant production suites at ADL. The role extends to the management of all works completed during planned non-commercial time to minimise the impact to the commercial schedules and to develop a standardised and robust system of right first-time maintenance or project delivery. The role also includes responsibility for identifying and executing projects to optimise and reduce non-commercial time requirements to increase plant availability.
Key Duties and Responsibilities
• Leads Safety and Quality Compliance during periods of non-commercial time and plant shutdown/slowdown. Supports the generation of permits (Safety/GMP) and shutdown forms. Conducts safety walks and provides technical input into incidents and investigations.
• Takes ownership of F&E shutdown planning and execution programs as part of the extended F&E Leadership Team.
• Communicate effectively, with an ability to influence and engage relevant stakeholders at all levels of the organisation to create mature and deliverable plans.
• Ability to develop a deep knowledge and understanding of activity prioritization, finite scheduling and the management of multiple workstreams and critical path activities.
• Become a subject matter expert on plant interdependencies and the co-ordination of tasks that have the potential to impact multiple utilities or production systems. Maximize plant availability to the site through parallel sequencing and level loading of activity.
• Collaborate with system owners and technicians to understand scope of proposed works and to plan resource requirements, detailed work instructions and schedules as required.
• Co-ordinates with relevant stakeholders across site functions to ensure smooth transitions between commercial & non-commercial activities are achieved with clear plans communicated, monitored, and completed by the cross functional team.
• Develop tools and processes to simplify task execution and build these into future plans by refining work instructions, documentation and job-plans.
• Create a cycle of continuous learning through planning, execution, review, and feedback to develop standard work for maintenance intervals and deliver high levels of equipment uptime and availability to the plants.
• Ability to foresee and escalate potential roadblocks and develop solutions to resolve.
• Supports Business Continuity Plans & Risk Management Programs for F&E.
Basic Qualifications:
• Bachelor’s degree in Engineering (Mechanical, Electrical / Electronic, Software / Chemical) or equivalent qualification and/or experience.
• >5 years’ experience in cGxP manufacturing environment in a similar function or role.
• Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
Preferred Experience:
• Typically, 5+ years engineering experience in a pharmaceutical environment.
• > 3 years’ experience in aseptic fill / finish manufacturing.
• Proven planning and coordination experience in a complex environment.
Knowledge and Relevant Experience:
• Working knowledge of pharmaceutical/biotech industries and/or aseptic processing.
• Fundamental knowledge of applicable regulatory requirements (GxP & EHS).
• Strategic resource planning, scheduling and prioritisation.
• Knowledge of relevant computer systems and applications (e.g. Maximo)
• Application of continuous improvement tools and methodologies.
Skills:
• Team player who actively promotes a culture that relies on collaboration and engagement at all relevant levels for effective decision-making.
• Commands respect with the ability to assess and influence the impact, both short and long-term, of decisions that impact plant availability.
• Time and resource management skills at both tactical and strategic levels.
• Excellent technical writing and communication skills (verbal and written) at all levels.
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