About the Role:
We are seeking a highly skilled Validation 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 on Cleaning Validation, including Recovery/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 in Cleaning 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 in GMP manufacturing with expertise in exception/deviation management, change control, and technical project leadership.
* Relevant qualification in Pharmaceutical/Biological/Chemical Sciences or Engineering.
* Knowledge of process monitoring systems, automation (DeltaV), and operational intelligence (Pi System) is desirable.
* Familiarity with sterile fill-finish processes, filter validation, autoclave/SIP sterilisation, and isolator VHP/HVAC qualification.
* Proficiency in Microsoft Office and excellent communication, presentation, and interpersonal skills.
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