Validation Engineer

1 week ago

Carlow, Ireland Recruitment by Aphex Group Full time

This is an 11-month contract and is a hybrid position, About the Role: We are seeking a highly skilledValidation Engineer to join our team in a cGMP regulatory environment. This is an exciting opportunity for an experienced professional to take on a challenging role, focusing onCleaning Validation, includingRecovery/Cleanability studies, and driving compliance in a GMP manufacturing setting. Key Responsibilities: Design, author, review, approve, and execute qualification/validation documentation, including cycle development studies. Lead change control execution and development, resolving technical issues during study execution. Collaborate with Production, Maintenance, and Quality teams during Cycle Development & Performance Qualification activities. Provide technical input into quality notifications, investigations, and root cause analysis of system failures. Support continuous improvement initiatives using Lean Six Sigma methodologies. Represent the validation team in cross-functional projects and global technical forums. Ensure compliance with global policies, regulatory requirements, and cGMP standards. Support regulatory audits and submissions as required. Qualifications: Proven experience inCleaning Validation, including CD & PQ of mobile vessels (CIP), parts washers (COP), recipe development, cleaning verification, and recovery studies using TOC, ICP, and swab methods. Strong background inGMP manufacturing with expertise in exception/deviation management, change control, and technical project leadership. Relevant qualification inPharmaceutical/Biological/Chemical Sciences orEngineering. Knowledge of process monitoring systems, automation (DeltaV), and operational intelligence (Pi System) is desirable. Familiarity withsterile fill-finish processes,filter validation,autoclave/SIP sterilisation, andisolator VHP/HVAC qualification. Proficiency in Microsoft Office and excellent communication, presentation, and interpersonal skills.

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