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
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