Validation Engineer – RBK Chartered Accountants
Our client, a privately owned Irish company based in Longford, is seeking to recruit a Validation Engineer. This person will be responsible for supporting all validation activities associated with the successful qualification of new tools and product introductions.
The role reports to the Validation Engineer Manager and supports the organization to achieve new product introduction objectives.
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.
Develop and implement solutions to sustain and improve the QMS.
Maintain and support compliance with ISO 13485 and ISO 14001 systems standards.
Participate in site change control, ensuring that all changes to validated processes are effectively identified and implemented.
Generate risk assessments covering cleaning, validation, and process.
Review and execute Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) protocols.
Directly support GMP and regulatory audits.
Prepare and deliver training modules as required.
Perform data analysis and make informed decisions/recommendations based on conclusions reached.
Support continuous improvement through Lean Six Sigma methodologies.
Execute/develop change controls.
Perform root cause analysis of system failures and substandard performance, using standard tools and methods (e.g., FMEA, Fishbone diagrams, 5‑whys).
Implement corrective actions through the change management system.
Participate or lead cross‑functional teams, including liaising with vendors on projects.
Qualifications & Key Attributes
Third‑level qualification in Engineering, Polymer Science, or equivalent manufacturing experience.
Experience in statistical analysis (Minitab), SPC, and validations.
Excellent interpersonal, communication, influencing, and facilitation skills.
Minimum of 2 years’ experience as a Validation Engineer within an injection moulding or medical manufacturing environment.
Requirements
Minimum of 5 years’ experience working with medical devices.
Strong expertise and knowledge of injection moulding.
Proven track record in validation within regulated environments.
Other Details
Seniority Level: Not Applicable
Employment Type: Full‑time
Job Function: Quality Assurance
Industry: Accounting
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