About the Role:
We are seeking a highly skilled Clean Utilities Specialist to join our team for an initial 12-month contract on an exciting project.
The successful candidate will be responsible for ensuring the quality and compliance of clean utilities systems at a sterile drug product filling line project.
Key Responsibilities:
* Develop and execute comprehensive testing documentation for clean utilities systems.
* Meet key project deliverables for safety, schedule, and quality of project-related documentation/electronic records for equipment and utilities assigned.
* Ensure GMP equipment and clean utilities are tested in compliance with good manufacturing practices, company policies, and EU & FDA regulations.
* Deviation management associated with assigned equipment and utilities.
* Risk Management – Identify and categorize CQV risks according to impact on commissioning and qualification, generate action plans to mitigate qualification risks.
* Execute FAT testing and leverage results into overall qualification process for assigned equipment, facilities, and utilities.
* Ensure all assigned training is executed on time to meet site metrics.
Requirements:
* A minimum of a BS qualification (Degree) in a scientific, technical, or engineering discipline.
* 5 years of experience within the pharmaceutical industry, ideally with familiarity with sterile drug product filling line experience.
* Demonstratable capacity to effectively execute the testing approach for assigned projects from initiation to completion.
* CQV project lifecycle experience from design through to C&Q and handover.
* Demonstrable experience of performing as part of diverse teams of CQV professionals/contractors to deliver tasks safely, with a quality focus, on time, and within budget.
* Experience in CQV of drug substance/drug product sterile manufacturing equipment and utilities with integrated automation.
* Specifically, experience with CQ of high-purity water systems, purified water & WFI generation and distribution systems, and clean steam and high-purity gas systems.
* Solid background of document preparation, execution, and task planning on CQV projects with a demonstrated record of on-time performance.
* Excellent communication skills and the ability to influence others.
* Demonstratable experience working in teams in a matrix environment to deliver CQV elements.
* Previous experience with electronic validation platforms (e.g., ValGenesis, Kneat).