Company Profile
Our client is a leading multinational biopharmaceutical organization based in Dublin and they are hiring for a C&Q Inspection Engineer on an initial 12‑month contract. The role will be based at a highly modernised site with cutting‑edge equipment and an exciting new project to aid delivery. If you have a background in CQV relating to inspection equipment and are looking for your next contract, please reach out today!
Key Responsibilities
* Development and execution of CQV testing documentation for inspection systems including syringe and vial automated visual inspection equipment and manual inspection booths for the sterile drug product facility.
* Responsible for meeting key project deliverables for safety, CQV schedule and quality of project‑related documentation and electronic records for equipment and utilities.
* Ensure GMP equipment are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
* Ensure all inspection equipment is tested in compliance with project‑related standards from a commissioning perspective.
* Manage deviations associated with the assigned equipment and utilities.
* Risk management – identify and categorise 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.
Essential Requirements
* Minimum of a BS qualification (degree) in a scientific, technical or engineering discipline with at least 5 years of experience within the pharmaceutical industry, ideally with familiarity with sterile drug product filling line experience.
* Demonstratable capacity to effectively execute the CQV testing approach for assigned projects from initiation to completion.
* CQV project lifecycle experience from design through to C&Q and handover.
* Demonstrable experience performing as part of a diverse team 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 with integrated automation.
* Experience in leading, managing and executing FAT activities.
* Solid background in 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.
* Demonstrable experience working in teams in a matrix environment to deliver CQV elements.
* Previous experience with electronic validation platforms ValGenesis or Kneat.
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