Validation Engineer – GMP & Process Excellence

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

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.