Validation Engineer

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/ product introduction.

He or She will report to the Validation Engineer Manager and will support the organization to achieve the 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.

• 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.

• Experience in statistical analysis (Minitab) / SPC / validations.

• Excellent interpersonal, communication, influencing, and facilitation skills

• A 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