Validation Engineer

Opto Recruitment; Longford; On-site; EUR 52,000 - 75,000; Full time

Job summary

Opto Recruitment seeks a Validation Engineer for a leading client in Athlone, Ireland. The role supports qualification of new tools/products and ensures compliance with quality systems.

Responsibilities include writing validation protocols, participating in change control, performing risk assessments, and supporting GMP/regulatory audits. Fluent English and strong communication are required.

Qualifications

• Third level qualification in Engineering, Polymer Science, or equivalent.

Responsibilities

• Write and execute validation protocols and reports for new product introductions and revalidations.
• Develop and implement solutions to sustain and improve the QMS.
• Maintain ISO 13485 and ISO 14001 compliance.
• Participate in site change control and manage validated processes changes.
• Generate risk assessments (cleaning, validation, process).
• Review and execute FAT and SAT protocols.
• Support GMP and regulatory audits.
• Prepare and deliver training modules.
• Perform data analysis and make decisions from data.
• Support Lean Six Sigma and continuous improvement.
• Execute/change controls and root cause analysis with tools like FMEA, Fishbone, 5 Whys.
• Lead cross functional teams including liaising with vendors.

Skills

Process validation

QMS improvement

Lean Six Sigma

Data analysis

Root cause analysis

Communication

Education

Engineering or Polymer Science degree

Tools

Minitab

Job description

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.