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