QA Validation Engineer

About the role

Cagents is actively seeking a QA Validation Engineer to join their growing team in Dublin. In this position, you will manage the full scope of qualification and validation activities for process and lab equipment across multiple sites. You will be responsible for ensuring that all systems and instruments comply with stringent regulatory requirements and industry best practices. A significant portion of your work will be conducted directly at major pharmaceutical and biotech facilities located throughout Ireland. You will act as a key subject matter expert for quality, engineering, manufacturing, and laboratory teams during critical project phases. The role requires a high level of ownership for the integrity of data, procedures, and final compliance documentation. You will be instrumental in driving process improvement and maintaining the highest standards of product and patient safety. Success in this position will depend on your ability to manage complex projects from initial planning through successful execution and closure.

Key facts

What you'll do

• Execute Installation Qualification (IQ) protocols to verify that equipment is installed correctly according to design and manufacturer specifications.
• Perform Operational Qualification (OQ) tests to confirm that systems operate within defined limits and functional requirements.
• Conduct Performance Qualification (PQ) studies to demonstrate that equipment consistently performs as intended under expected conditions.
• Author detailed validation protocols that outline procedures, acceptance criteria, and step-by-step test cases for system qualification.
• Review and audit validation documentation to ensure accuracy, completeness, and compliance with standard operating procedures.
• Oversee the complete project lifecycle of commissioning, qualification, and validation activities from initial risk assessment to final report sign-off.
• Lead risk assessment activities, including Failure Mode and Effects Analysis (FMEA), to prioritize validation efforts and mitigate potential issues.
• Manage change control processes to evaluate, document, and approve modifications to validated systems or procedures.
• Investigate and manage deviations, ensuring that investigations are thorough, timely, and documented in accordance with regulatory expectations.
• Coordinate and support audit preparations, providing necessary documentation and evidence to demonstrate compliance during internal and external inspections.
• Maintain rigorous lifecycle documentation for all equipment, ensuring that historical records are accurate, retrievable, and up to date.
• Collaborate with cross-functional teams to ensure clear communication of validation requirements, timelines, and deliverables.
• Drive continuous improvement initiatives related to equipment validation, leveraging best practices to enhance efficiency and compliance.
• Ensure strict adherence to Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) standards throughout all validation activities.

Requirements

• Hold a Degree in Science, Engineering, Biotechnology, or a related field from an accredited institution.
• Possess a minimum of 3 years of professional experience in validation within the medical device, biotech, life sciences, or pharmaceutical sectors.
• Demonstrate a proven background in qualifying manufacturing or laboratory equipment within GMP-controlled environments.
• Show proficiency in writing, executing, and reviewing validation documentation, protocols, and reports.
• Have a strong working knowledge of change control, deviation management, and CAPA workflows and their application in regulated settings.
• Exhibit the ability to manage stakeholders at various levels and communicate complex technical information clearly and effectively.
• Must hold legal authorization to work in Ireland and be able to obtain necessary security clearance if required by client sites.

Nice to have

• Familiarity with computerized systems and relevant regulatory guidance such as GAMP 5.
• Experience with specific validation software or Electronic Data Capture (EDC) systems.
• Understanding of EU Annex 11 and data integrity principles.
• Prior involvement in audit activities or inspection support within a regulated environment.

Practical notes

• This role includes a competitive salary and benefits package.
• You will gain exposure to diverse CQV projects across the Irish life sciences sector.
• The position may require travel between multiple client sites in and around Dublin.
• Candidates must be eligible to work in Ireland without sponsorship.
• The engagement is full-time, and successful candidates are expected to commit to the project schedule and client requirements.
• No visa sponsorship will be provided for this role.
• Applicants must meet all stated requirements; partial qualifications will not be considered.
• The selection process will include interviews and practical assessments relevant to validation competencies.