The validation engineer will primarily be responsible for developing, maintaining and improving a standardised validation process for the Plant to ensure compliance to required regulations within the engineering function. Participate as part of project team to ensure all validation requirements are met in accordance with project management procedures.
- Drive the engineering validation function in conjunction relevant departments i.e. QA/RA in the development and provisions of documentation for the qualification (IQ/OQ/PQ) related to agreed Plant validations.
- Working as a member of the engineering project team to review what projects require validation.
- Assist with URS development for software validation projects.
- Interact with other departments conducting the validations before protocols are written and again to review the validation data for the validation report.
- Ensure that all data, results and information associated with qualification and validation data provided for reports are in accordance with written procedures.
- Validation documentation;
- Implement, deploy and revise as applicable all Validation procedures.
- Development and maintenance of Validation Master Plans and Validation Strategies.
- Ensure that the plant master validation list is kept up to date and that approved records for all the validations listed and available in hard copy for audits.
- Writing and arranging approval of validation protocols and reports;
- Update validation protocol/reports with deviations report.
- Ensure continued compliance with all Regulatory Standards. This includes:
- ISO 13485, FDA QSR,
- Ensuring continued compliance with DMR
- Process Validation Guidance from the Global Harmonization Task Force (GHTF) - July, 1999.
- Related sterilisation validation standards.
- Interacting and presenting validation documentation during FDA, NSAI, Corporate and customer audits.
- Conduct training in Validation Methodologies and related procedures as required.
- Create and maintain Device Master Record (DMR) Documentation through the order entry and ECO process.
SKILLS AND KNOWLEDGE:
- Ability to communicate and work with people inside and outside the department.
- Good communicator (written and oral).
- Ability to train and lead where required.
- Ability to co-ordinate, plan and organise in a timely manner.
- Knowledge of engineering theories and methods, demonstrating an aptitude for analysis and problem solving.
- Rigorous attention to detail.
- Ability to work independently and without direct supervision while maintaining adherence to timelines is fundamental to the role.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
- Engineering or science Degree.
- Knowledge of Computer System Validation will be a distinct advantage.
- A Six Sigma qualification will be a distinct advantage.
- Good PC skills
For further information on this role please contact James on 016455250 or email@example.com