Validation Engineer

Summary

Our client, a biopharmaceutical company based in Carlow, is seeking a Validation Engineer to support validation activities in a cGMP regulated environment. The successful candidate will work across a range of validation areas, supporting equipment and system qualification, cycle development, and ensuring compliance with regulatory and quality standards.

Responsibilities

• Design, author, review, approve and execute qualification and validation documentation, including cycle development studies in line with standard approval processes
• Support the development and execution of change controls
• Troubleshoot and resolve technical issues encountered during study execution
• Collaborate with Production, Maintenance and Quality teams during execution of Cycle Development and Performance Qualification activities
• Provide technical input into quality notifications, including authoring, reviewing and approving investigations
• Perform root cause analysis of system failures and substandard performance using standard tools and methodologies
• Support continuous improvement initiatives using Lean Six Sigma methodologies
• Represent the validation function on cross functional projects and at technical forums
• Ensure compliance with internal policies, procedures, regulatory requirements and cGMP standards in all activities
• Maintain compliance through documentation completion, risk assessments, CAPA closure, and participation in audits and inspections
• Support regulatory audits and submissions as required
• Promote and contribute to a safe and compliant working environment
• Other duties as assigned

Qualifications & Experience

• Degree in Engineering, Science or a related technical discipline
• Experience working in a cGMP regulated environment (pharmaceutical, biopharmaceutical or similar)
• Hands on experience in equipment and/or process validation
• Experience with validation documentation, including protocol generation and execution
• Knowledge of deviation management, change control and investigation processes
• Experience with isolator systems, HVAC, VHP, E Beam or depyrogenation systems is advantageous
• Familiarity with thermal mapping and CTU equipment qualification is desirable
• Experience with process monitoring and automation systems (e.g. DeltaV, PI) is beneficial
• Proficiency in Microsoft Office and relevant technical systems