Description
A long term contract opportunity has arisen for an experienced Validation Engineer to work on this exciting New Build Project.Joining a large qualification team, as Validation Engineer you will be required to provide validation expertise on the documentation that has been created for this large scale new build project.
Your role is to support and manage the generation and execution of validation documentation and assist the C&Q lead through the Commissioning, Installation and Operational Qualification stages of a large project, and will be achieved by working effectively with the project team (SMEs) and communication with key stakeholders.
As Validation Engineer this role will fundamentally be more on the documentation side of the activities and free up some of the Leads time, writing the change controls/deviations, reviewing the protocols that have been written & co-ordinating deviations identified.
Key responsibilities:
- Manage C&Q change control and deviations by helping to coordinate, raise and close deviations with support from the SMEs, and providing a lookahead for the owners to enable resource planning
- Update validation documentation as required eg Validation Plans, URSs.
- Assist with project specific procedure updates and training out to the team where required
- Assist with closure of Audit responses in a timely manner
- Provide general validation expertise and advice to the C&Q team as required
- Review protocols for technical and GDP compliance
- Extensive Validation/C&Q experience
- Ability to write and execute protocols
- Coordinate validation activities, complete change controls, deviations etc
- Have sterile validation environment experience
- Experience of working within a project team environment