Walker Cole International is supporting a leading pharmaceutical manufacturer in the search for a Validation Project Manager - Cleaning & Process to join their site based in South East England.
In this role, you will be responsible for managing the Cleaning and Process Validation programme across a biologics manufacturing site. You will ensure GMP compliance and regulatory alignment in validation strategy and execution, whilst acting as the subject matter expert for cross-functional projects.
Key Responsibilities:
* Lead and deliver Cleaning Validation and Process Validation projects, ensuring alignment with internal standards and MHRA/FDA requirements.
* Prepare, review, and execute validation lifecycle documents including protocols (URS, IQ, PQ, OQ etc.) and reports.
* Collaborate across Quality, Manufacturing, and Engineering functions to maintain validated status and support capital project initiatives.
* Author and maintain SOPs, Work Instructions, and policy documents aligned with validation standards.
Experience Required:
* A degree in a scientific or engineering discipline, or equivalent industry experience.
* Relevant industry experience in cleaning and/or process validation within a GMP pharmaceutical setting.
* Strong understanding of EU and FDA regulatory expectations for validation and quality compliance.
* Proven ability to manage validation projects and influence cross-functional teams.
Good Manufacturing Practice | GMP | MHRA | Process Qualification | Cleaning Validation | URS | IQ | PQ | OQ | Qualification | Validation | FDA