Remote Validation Specialist – AI-Driven Documentation

OPTEL Vision Ltd; Limerick; Hybrid; EUR 40,000 - 60,000; Full time

Job summary

OPTEL Vision Ltd is seeking a Validation Specialist - Middleware Solutions to develop and maintain validation documents (IQ, OQ, Change Controls) and ensure regulatory compliance. The role emphasizes collaboration with internal teams and clients to deliver high‑quality validation artifacts.

You will drive continuous improvement, utilize AI tools for drafting and review, and stay aligned with GAMP, 21 CFR Part 11, and EU Annex 11 standards.

Qualifications

• College diploma in a relevant field.
• Minimum 2 years in system testing and validation or technical writing.
• Excellent English (written and spoken).
• Advanced knowledge of Microsoft Office suite (Word/Excel).
• Familiarity with VBA macros is a plus.
• Interest in applying AI to document drafting and review.

Responsibilities

• Create and maintain validation documents (IQ, OQ, Change Controls).
• Maintain validation templates to ensure regulatory compliance (GAMP, FDA 21 CFR Part 11, EU Annex 11).
• Identify opportunities for continuous improvement and automation.
• Review system updates to assess impact on validation documents.
• Generate client validation documents from project specifications.
• Lead validation-discrepancy investigations and corrective actions.
• Collaborate with internal teams and clients to deliver validation artifacts.
• Participate in audits to ensure compliance with quality systems.

Skills

Validation

Documentation

Team collaboration

English proficiency

Continuous improvement

Analytical thinking

AI tooling interest

Education

College diploma in a relevant field

Level 7 Diploma / Ordinary Bachelor Degree

Tools

Microsoft Word

Microsoft Excel

VBA macros

Job description

OPTEL Vision Ltd is seeking a Validation Specialist - Middleware Solutions to develop and maintain validation documents (IQ, OQ, Change Controls) and ensure regulatory compliance. The role emphasizes collaboration with internal teams and clients to deliver high‑quality validation artifacts.

You will drive continuous improvement, utilize AI tools for drafting and review, and stay aligned with GAMP, 21 CFR Part 11, and EU Annex 11 standards.