Only 24h Left: Shutdown
2 weeks ago
Apply remote type On Site locations Ireland - Dublin time type Full time posted on Posted 2 Days Ago job requisition id R-208041
Career Category
Engineering
Job Description
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
1. 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.
2. Takes ownership of F&E shutdown planning and execution programs as part of the extended F&E Leadership Team.
3. Communicate effectively, with an ability to influence and engage relevant stakeholders at all levels of the organisation to create mature and deliverable plans.
4. Ability to develop a deep knowledge and understanding of activity prioritization, finite scheduling and the management of multiple workstreams and critical path activities.
5. 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.
6. Collaborate with system owners and technicians to understand scope of proposed works and to plan resource requirements, detailed work instructions and schedules as required.
7. 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.
8. Develop tools and processes to simplify task execution and build these into future plans by refining work instructions, documentation and job-plans.
9. 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.
10. Ability to foresee and escalate potential roadblocks and develop solutions to resolve.
11. Supports Business Continuity Plans & Risk Management Programs for F&E.
Basic Qualifications:
1. Bachelor's degree in Engineering (Mechanical, Electrical / Electronic, Software / Chemical) or equivalent qualification and/or experience.
2. >5 years' experience in cGxP manufacturing environment in a similar function or role.
3. Demonstrated leadership skills with the ability to build teams and operate across functional boundaries, both internal and external.
Preferred Experience:
1. Typically, 5+ years engineering experience in a pharmaceutical environment.
2. > 3 years' experience in aseptic fill / finish manufacturing.
3. Proven planning and coordination experience in a complex environment.
Knowledge and Relevant Experience:
1. Working knowledge of pharmaceutical/biotech industries and/or aseptic processing.
2. Fundamental knowledge of applicable regulatory requirements (GxP & EHS).
3. Strategic resource planning, scheduling and prioritisation.
4. Knowledge of relevant computer systems and applications (e.g. Maximo)
5. Application of continuous improvement tools and methodologies.
Skills:
1. Team player who actively promotes a culture that relies on collaboration and engagement at all relevant levels for effective decision-making.
2. Commands respect with the ability to assess and influence the impact, both short and long-term, of decisions that impact plant availability.
3. Time and resource management skills at both tactical and strategic levels.
4. Excellent technical writing and communication skills (verbal and written) at all levels.
About Us
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.
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