Our leading client leading client in Athlone are looking to hire a
Validation Engineer
on either a contract of permanent basis. The Validation Engineer is responsible for supporting all validation activities associated with the successful qualification of new tools / product introduction.
Key Responsibilities:
* Write and execute process validation protocols and reports for new product introductions and revalidations due to process /material improvements utilizing scientific / technical knowledge.
* Developing and implementing solutions to sustain and improve the QMS.
* Maintain and support compliance to ISO 13485 and ISO 14001 systems standards.
* Participate in the site change control, ensuring that all changes to validated processes are effectively identified and implemented.
* Generation of risk assessments, covering cleaning, validation, and process.
* Review and execution of Factory Acceptance Testing and Site Acceptance Testing protocols.
* Directly supports GMP and regulatory audits.
* Prepare and deliver training modules as required.
* Perform data analysis and make informed decisions / recommendations around conclusions reached from data analysis
* Support continuous improvement through Lean Six Sigma methodologies.
* Execution / development of change controls.
* Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc.;
* Implement subsequent corrective action through the change management system.
* Participate / lead cross functional teams including liaising with vendors on projects.
Qualifications & Key Attributes
* Third level qualification in Engineering, Polymer Science, or equivalent Manufacturing experience.
* A minimum of 2 years' experience as a Validation Engineer within an Injection moulding or medical manufacturing environment.
* Excellent interpersonal, communication, influencing, and facilitation skills.
* Experience in statistical analysis (Minitab), SPC, and validations.
* Fluent in English, with strong written and verbal communication skills.