Role Description:
We are seeking a skilled Validation Engineer to join our team. This is an exciting opportunity to work in a dynamic manufacturing environment with a highly experienced team.
The successful candidate will be responsible for writing and executing process validation protocols and reports, developing solutions to sustain and improve the Quality Management System (QMS), and maintaining compliance to ISO standards.
Prior experience in medical device and/or injection moulding is essential. The ideal candidate will have a third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience, as well as excellent interpersonal and communication skills.
The Validation Engineer will participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented. They will also generate risk assessments, review and execute Factory Acceptance Testing and Site Acceptance Testing protocols, and directly support Good Manufacturing Practice (GMP) and regulatory audits.
In addition, the successful candidate will prepare and deliver training modules, perform data analysis, and make informed decisions based on the conclusions reached from data analysis. They will also support continuous improvement through Lean Six Sigma methodologies and implement subsequent corrective action through the change management system.
Requirements:
* Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience
* Experience in statistical analysis / SPC / validations
* Excellent interpersonal, communication, influencing, and facilitation skills
* Prior experience as a Validation Engineer within an Injection moulding or medical manufacturing environment
This is a fantastic opportunity for a motivated and experienced professional to take their career to the next level.