Product Validation Specialist
This is an exciting opportunity to contribute to the development and implementation of robust validation processes. As a Product Validation Specialist, you will play a key role in ensuring product quality and compliance.
Key Responsibilities:
* Develop and execute process validation protocols and reports for new product introductions and revalidations.
* Collaborate with cross-functional teams to drive continuous improvement through Lean Six Sigma methodologies.
* Ensure compliance with relevant industry standards such as ISO 13485 and ISO 14001.
* Lead vendors on key projects and conduct risk assessments to inform decision-making.
* Review and execute FAT and SAT protocols, and support GMP and regulatory audits.
* Deliver training and mentor colleagues to strengthen validation knowledge across the business.
* Perform data analysis to guide informed decision-making and improvements.
Requirements:
* Third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
* Minimum 2 years' experience as a validation specialist in injection moulding or medical device manufacturing.
* Strong background in statistical analysis (Minitab), SPC, and validation methodologies.
* Excellent communication, interpersonal, and influencing skills.
* Hands-on experience in problem solving (FMEA, Fishbone diagrams, 5 Whys, etc.).
Why Join?
Be part of an innovative team driving process excellence and new product introduction. Work in a regulated environment with opportunities to expand your expertise. Flexible engagement options are available to suit your career path.