QA Validation Engineer

Role Overview

Join CAI as a QA Validation Engineer to engage in advanced pharmaceutical and biotechnology projects throughout Ireland. This position involves facilitating qualification and validation procedures for laboratory and manufacturing equipment supporting GMP-regulated processes in cutting-edge life sciences operations.

Main Responsibilities

• Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for GMP compliant equipment and systems.
• Create, critique, and maintain validation protocols, reports, and complete lifecycle documentation.
• Assist with commissioning, qualification, and validation tasks starting from the planning phase to execution completion.
• Carry out risk assessments and contribute to managing deviations, Corrective and Preventive Actions (CAPA), and change control activities.
• Ensure adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and applicable regulatory standards.
• Collaborate effectively with cross-functional teams including Quality, Engineering, Manufacturing, and Laboratory departments.
• Participate actively in audit processes and prepare for inspection readiness.
• Support management of equipment lifecycle and initiatives focused on continual improvement.

Candidate Requirements

• A university degree in Engineering, Science, Biotechnology, or a closely related field.
• Minimum of three years’ hands-on validation experience within pharmaceutical, biotech, medical device, or life sciences sectors.
• Proven background in qualifying laboratory and/or manufacturing equipment within GMP-regulated environments.
• Comprehensive knowledge of GMP guidelines and validation methodologies.
• Experience in authoring and executing various validation documentation protocols.
• Familiarity with deviation handling, change control, and CAPA workflows.
• Excellent communication skills with strong stakeholder engagement capabilities.
• Robust technical writing expertise and problem-solving aptitude.
• Must be authorized to work in Ireland.

Why Choose CAI?

• Collaborate with top-tier pharmaceutical and biotech companies across Ireland.
• Gain exposure to diverse validation and Commissioning, Qualification, and Validation (CQV) projects.
• Opportunities for career progression within an expanding international organization.
• Engage in a team-oriented, supportive work culture.
• Receive a competitive remuneration package and benefits.

About CAI

CAI is recognized globally for excellence in commissioning, qualification, validation, and operational readiness services dedicated to the pharmaceutical, biotechnology, and life sciences sectors. We partner with leading manufacturers to deliver innovative, compliant solutions that uphold quality and regulatory standards.

Additional Information

Artificial Intelligence (AI) tools may be employed during the recruitment process to assist with reviewing applications and analyzing candidate submissions. These tools augment but do not replace human decision-making, with final hiring determinations made by personnel. For inquiries regarding data management, please contact CAI directly.