Description
World leading Pharmaceutical client has an exciting and long term contract assignment for an experienced VALIDATION ENGINEER.Working on a £100million New Build secondary filling facility we are looking for a seasoned Validation Engineer 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.
This will involve working within a large project qualification team and will be achieved by working effectively with the project team (SMEs) and engagement and communication with key stakeholders.
You will primarily be responsible for the documentation side of of the activities, taking on some of the work from the SMEs for writing the change controls/deviations and co-ordinating them.
Key responsibilities:
- Manage C&Q change control and deviations by helping to co-ordinate, 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 e.g. 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
Key Skills and Experience needed:
- Extensive Validation/C&Q experience
- Ability to write and execute protocols
- Co-ordinate validation activities, complete change controls, deviations etc
- Have sterile validation environment experience
- Experience of working within a project team environment
- Any secondary bulk filling experience advantageous