Brightwork are supporting with the recruitment of a Validation Engineer for one of our manufacturing clients in Ayrshire.
You will be responsible for the validation, qualification and verification of various processes, equipment and systems in accordance with the annual validation schedule.
- Writing validation plans and protocols, executing validation exercises, analysing results and compiling related reports.
- Initial focus will be the Aseptic Fill validation process or media fill, ensuring regulatory requirements are met.
- Investigate and resolve relevant deviations and CAPA plans relating to validation exercises and validated systems.
- Participation in root cause analysis
- Support site projects and new equipment purchases as required.
- You will provide support and guidance across the site for project, process and system issues.
- Active participation in the relevant change control and risk evaluation systems.
- Active participation in process improvement initiatives as required
The successful candidates will possess:
- A scientific or engineering degree
- Knowledge/experience working within a manufacturing/production, lab or engineering environment.
- Practical working experience of the European GMP regulations as described in Annex 11 and 15 of the EU Guidance on Good Manufacturing Practice
- Proven experience of coordinating validation exercises in accordance with approved validation protocols, collating results and generating summary reports
- Knowledge of validation relating to aseptic processing, medical device cGMP and sterilisation systems would be preferred.
- Previous experience and/or participation in customer or regulatory audits would be preferred
- Excellent communicator with ability to liaise with multi-disciplinary teams
- Excellent planning and organisational skills
- Demonstrates a sense of urgency working to tight deadlines
- Ability to critically review and present data
Brightwork Ltd offers the services of an employment agency for permanent work and an employment business for temporary work.