Job Description
We are seeking a skilled Validation Engineer to support a new project in ensuring the on-going validation and compliance of new equipment, systems and processes.
The successful candidate will be responsible for executing FAT/SAT/IOQ protocols including generation of protocols and reports. They will also design, execute and report on validation studies for equipment, systems and processes. Additionally, they will ensure that validation studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.).
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Required Skills and Qualifications
* Experience: 3-5 years' experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
* Capable of troubleshooting validation issues associated with projects, process development etc.
* Competent technical knowledge of pharmaceutical plants.
* Previous validation/product development experience would be highly advantageous for the role.
* Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
* Knowledge of requirements for GAMP, ISPE Baseline guides.
* Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
* Full understanding of relevant quality and compliance regulations.
* Able to execute projects to plan.
* Good knowledge of quality management systems.
* Good communication skills at organisation, team and individual levels.
* Ability to use MS Project and SPC packages an advantage.
* Understands KPI's for the site.
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About the Role
This is a fantastic opportunity to work with our team and contribute to the success of our organization. If you are a motivated and experienced Validation Engineer looking for a new challenge, we encourage you to apply.