Overview
New Material Introduction (NMI) & Material Qualification (MQ) Specialist – Dunboyne, County Meath, Ireland. A fantastic opportunity to join a state of the art single use multi-product biotech facility. The role involves evaluation, qualification and lifecycle management of materials used at the site. Ensure new and existing materials meet regulatory, quality and safety requirements through rigorous testing, supplier qualification and cross-functional collaboration to enable reliable, compliant and cost-effective supply, supporting product integrity and patient safety.
Responsibilities
* Lead end-to-end new material introduction (NMI) activities, from technical evaluation and supplier qualification.
* Plan, coordinate and execute material qualification to ensure new materials comply with industry regulations, safety standards and product-specific requirements.
* Generate and review technical documentation required for material approval.
* Ensure new materials are introduced on site to enable successful release to meet schedule needs while maintaining safety and quality.
* Serve as the primary interface for material suppliers, procurement, R&D, process engineering, QA, regulatory and operations for NMI projects.
* Responsible for materials introduction and qualification processes; collaborate with partners to refine processes in alignment with regulatory and company procedures and support audits.
* Maintain and update the approved materials list and qualified materials database.
* Drive root-cause corrective actions and preventive measures for recurring material issues; lead cross-functional continuous improvement projects.
* Continuously improve the NMI & MQ process on site.
* Build strong relationships with suppliers to create and deliver value for the site.
Skills and Qualifications
* Bachelor’s degree in engineering, pharmacy or science-related field.
* Minimum four (4) years of previous experience within a supply chain or technical role related to new product introduction in a pharmaceutical environment.
* Sense of initiative and urgency; ability to work with multiple stakeholders to develop process-based solutions and manage communications effectively.
* SAP systems knowledge (master data, production execution modules).
* Ideally, experience with single-use materials and applicable regulatory standards for qualification of single-use materials.
* Experience engaging with vendors on material-related issues including supply chain notifications and investigations.
* Effective communication to manage internal and external stakeholders.
* Collaboration skills and a teamwork mindset.
* Enterprise mindset to prioritize site needs.
* Computer literacy with advanced MS Office skills, especially Excel.
* Willingness for continuous learning and a continuous improvement mindset.
Other Job Requirements
This role is hybrid; onsite support will be required based on day-to-day activities.
We are committed to keeping the patient at the heart of our work and strive to find solutions for healthcare needs. We are an equal opportunity employer and value bringing diverse, talented, and committed people together. For support during the recruitment process, please contact the Talent Acquisition Advisor assigned to this role. We support flexible working where possible and offer a hybrid working model for office-based colleagues. Please speak to us about what flexibility means to you during your application.
Additional
Required Skills: Adaptability, Analytical Thinking, Communication, Cross-Functional Communications, Customer Experience Management, Data Analysis, Driving Continuous Improvement, Financial Forecasting, Inbound Logistics, Inventory Control Management, Logistics Management, Management Process, MRP Systems, Production Planning, Six Sigma, Statistical Methods, Supply Chain Metrics, Vendor Selection
Preferred: Current Employees apply HERE; Current Contingent Workers apply HERE
Requisition ID: R366953
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