Description
To undertake all the necessary project validation tasks and some project engineering tasks.Duties:
Lead and manage the validation work associated with projects and project engineering activities, including:
- Authoring and management of validation documentation throughout the project life cycle, including URS IQOQ documentation.
- Identification of project requirements.
- Performing work in accordance with the project scope, project plan and project schedule.
- Follow the project life cycle for implementation of equipment.
- Management of the change control process, including raising ECCs and other documentation as applicable.
- Create & maintain requirements traceability Matrix.
- Liaise across the project team and to wider cross functional group to deliver all validation aspects of the project.
- Resolve technical issues with suppliers where appropriate.
- Perform FATs at the suppliers, including organising a team of individuals performing the FATs.
- Organise works required to install machines/new lines.
- Issuing and/or receiving permit to works and control of contractors for works required for installation of equipment.
- Commissioning and Validation of equipment in line with project schedule.
- Handover of equipment to production.
- Feed into action, decision and risk logs; provide info to PM for creation of project reports.
- Management of the change control process.
- Create & maintain requirements traceability Matrix.
- Liaise across the project team and to wider cross functional group to deliver all validation aspects of the project.
- Identification of full project requirements.
- Delivery of schedule for these works.
- Ensure all appropriate stakeholders are involved throughout the project life cycle, including EHS and validation.
- Attend project meetings where required.
- Project plan delivered through to stream governance.
- Gain understanding of all constraints and produce an implementation plan where required.
- Perform FATs at the suppliers, including organising a team of individuals performing the FATs.
- Organise works required to install machines/new lines.
- Issuing and/or receiving permit to works and control of contractors for works required.
- Progress supplier deliveries.
- Create IQOQ documentation where applicable.
- Commissioning and Validation of equipment in line with project schedule.
- Handover of equipment to production.
- Feed into action, decision and risk logs.
- Experience of commissioning and validation of Pharmaceutical HVAC & Utility Systems is preferred.