COMMISSIONING & QUALIFICATION ENGINEER
Responsibilities
1. Generation, Execution / Approval of Qualification Life Cycle documents from SLIA through to PQ and Final Summary Reporting for Direct Impact Systems.
2. Generation of Commissioning Test documents for No Impact Systems.
3. Implementation of Change Controls on the change management system to support project activities as applicable.
4. The role requires someone to coordinate and manage all elements of commissioning & qualification of large and small scale projects.
5. Responsibilities will be but are not limited to:
6. Developing a project plan and qualification strategy in line with Abbvie requirements.
7. Project activities may include but not are not limited to the following: Process equipment, Clean Utilities, HVAC & Facilities.
8. Coordinate and supervise third party suppliers / vendors, service providers and sub-contractors as necessary.
9. Monitor and report on project plan progress, communicate any shortfalls in specific areas of the plan and where needed identify solutions to address the shortfalls.
10. Organise and or attend any necessary meetings that are required for progress gathering or plan alignment
11. Participate in decision forums to decide on priorities and ensure these are reflected in the plan, schedule and communications.
12. Where needed evaluate allocation of resources needed to complete project tasks and provide recommendations to maintain required progress.
13. To communicate with project stakeholders required support and completion dates.
14. If assigned a budget for project execution: Monitor budgets closely reporting on funding committed, expenditure forecasting and progress.
Requirements
15. Degree in Engineering or related discipline is a necessary requirement for this position with project management experience.
16. 5 years' experience in projects in the Pharmaceutical or Biotech /Medical devices sector or Major project environment.
17. Can demonstrate a knowledge of Systems and Equipment and engineering design.
18. Ability to communicate clearly and in a timely manner to keep Company/Contractor personnel abreast of on-going changes and potential changes.
19. Proven ability to adapt in a changing environment and changing methods of working and project requirements / priorities.
20. Ability to work flexibly with the other members of project teams.
21. Ability to organise and prioritise own workload and meet deadlines.
22. Must be able to multi task and deal with regular interruptions and work scope execution.
23. Demonstrates the highest levels of integrity and a strong work ethic at all times.
24. Strong communication skills both verbal and written are required for the execution of this role.
#LI-MS2