Job Title: Validation Engineer
About the Role:
We are seeking an experienced Validation Engineer to join our team. As a key member of our organization, you will play a critical role in ensuring the highest standards of product quality and compliance.
About You:
* You have a third-level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
* You possess minimum 2 years' experience as a Validation Engineer in injection moulding or medical device manufacturing.
* You have a strong background in statistical analysis (Minitab), SPC, and validation methodologies.
* You excel in communication, interpersonal, and influencing skills.
* You have hands-on experience in problem-solving (FMEA, Fishbone diagrams, 5 Whys).
About Our Organization:
We offer a dynamic work environment that fosters innovation and excellence. This is a great opportunity to work on cutting-edge projects and develop your skills further.
Responsibilities:
1. Develop and execute process validation protocols and reports for new product introductions and revalidations.
2. Contribute to continuous improvement through Lean Six Sigma methodologies.
3. Ensure compliance with ISO 13485 and ISO 14001 standards.
4. Lead cross-functional teams, including vendor liaison on key projects.
5. Conduct risk assessments and root cause analyses, implementing corrective actions via change management.
6. Review and execute FAT and SAT protocols.
7. Support GMP and regulatory audits.
8. Deliver training and mentor colleagues to strengthen validation knowledge across the business.
9. Perform data analysis to guide informed decision-making and improvements.
What We Offer:
This position offers flexibility as it is available on either a permanent or subcontract arrangement basis.