Job Title: F&E Shutdown & Non-Commercial Time Co-ordinator
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.
Key Responsibilities:
1. Leads Safety and Quality Compliance during periods of non-commercial time and plant shutdown/slowdown.
2. Takes ownership of F&E shutdown planning and execution programs as part of the extended F&E Leadership Team.
3. Communicates effectively with stakeholders at all levels to create mature and deliverable plans.
4. Develops a deep knowledge and understanding of activity prioritization, finite scheduling and workstream management.
5. Becomes a subject matter expert on plant interdependencies and task co-ordination.
6. Collaborates with system owners and technicians to plan resource requirements and schedules.
7. Co-ordinates with stakeholders across site functions to ensure smooth transitions between commercial & non-commercial activities.
8. Develops tools and processes to simplify task execution and build these into future plans.
9. Creates a cycle of continuous learning through planning, execution, review and feedback.
10. Foresees and escalates potential roadblocks and develops solutions to resolve.
11. Supports Business Continuity Plans & Risk Management Programs for F&E.
Basic Qualifications:
* Bachelor's degree in Engineering 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.
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 promotes collaboration and engagement at all levels.
* Commands respect with the ability to assess and influence the impact of decisions.
* Time and resource management skills at both tactical and strategic levels.
* Excellent technical writing and communication skills at all levels.