New Material Introduction

Job Description
A fantastic opportunity has arisen for a New Material Introduction & Material Qualification Specialist at our new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland.
They will be responsible for the evaluation, qualification and lifecycle management of materials used in site. Ensure new and existing materials meet regulatory, quality and safety requirements through rigorous testing, supplier qualification and cross-functional collaboration, enabling reliable, compliant and cost-effective supply to support product integrity and patient safety.
Bring energy, knowledge, innovation to carry out the following:
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 need as well as balancing safety first, quality always.
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 process. Work with partners to manage these activities and refine the processes in alignment with regulatory & company procedures and support regulatory and company compliance audits.
Maintain and update the approved materials list, 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 an excellent relationship with suppliers assigned to ensure value is created and delivered for the site.
What skills you will need:
In order to excel in this role, you will more than likely have:
Bachelor’s degree in engineering, pharmacy or science related field.
Minimum four (4) years previous experience within a Supply Chain or technical role associated with 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 the associated communications effectively.
SAP systems knowledge– master data, production execution modules.
Ideally, experience of single-use materials and applicable regulatory standards for the qualification of single use materials.
Previous experience with engagement with vendors on material related issues including supply chain notifications and investigations.
Effective communicator to manage both internal and external stakeholders that support the site.
Collaboration skills and teamwork mindset.
Enterprise mindset to ensure the right priorities are set for the site.
Computer literate with advanced skills in MS Office, especially Excel.
Ability and willingness for continuous learning.
Ability to challenge the status quo with a continuous improvement mindset.
Other Job Requirements
This role is a hybrid role; onsite support will be required based on day-to-day activities.
As a company, we are committed to keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Our company is an equal opportunities employer and welcomes applications from all qualified candidates.

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