CQV Engineer

• 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.

• 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.

Cpl Group