NMI & MQ Specialist

TYPE OF CONTRACT: Employment Contract

DURATION: 11 months (with the possibility of extension)

WORK SCHEDULE: Standard Business Hours (Mon–Fri, no shift work)

WORK MODEL: Hybrid (3 days per week onsite in Dunboyne, Ireland)

PAY RATE: 20.12 - 34.17 €/h

OUR CLIENT

Our client is a leading global biopharmaceutical enterprise dedicated to developing, manufacturing, and delivering innovative medicines and therapeutic solutions worldwide. Operating state-of-the-art facilities, they are committed to upholding the highest standards of regulatory compliance, product quality, and patient safety.

SUMMARY

We are seeking a driven and detail-oriented New Material Introduction & Material Qualification (NMI & MQ) Specialist to join our client's site-level team. In this pivotal role, you will be responsible for the end-to-end evaluation, qualification, and lifecycle management of materials utilized on-site. You will ensure that both new and existing materials consistently meet stringent regulatory, quality, and safety requirements. By bridging supply chain logistics, quality assurance, and engineering, you will ensure a compliant and uninterrupted supply chain supporting patient safety.

ROLE FUNCTIONS

• Change Control & Gap Resolution: Manage Change Control (CC) processes and drive resolution of operational or technical gaps arising from Supplier Change Notifications (SCN) submitted by vendors.
• New Material Introduction (NMI): Lead end-to-end NMI activities, from initial technical evaluations through to full supplier qualification and site integration.
• Material Qualification Execution: Plan, coordinate, and execute material qualification activities to guarantee that all new components comply with industry regulations, safety standards, and product specifications.
• Technical Documentation & Compliance: Generate, review, and maintain technical documentation, qualification packages, and master databases required for material approval and audit readiness.
• Cross-Functional Interface: Act as the primary technical point of contact between material suppliers, Procurement, R&D, Process Engineering, Quality Assurance (QA), Regulatory Affairs, and Site Operations.
• Continuous Improvement & Root Cause Analysis: Lead root-cause investigations, implement Corrective and Preventive Actions (CAPA) for recurring material issues, and drive site-wide continuous improvement initiatives.

EXPERIENCE, SKILLS AND QUALIFICATIONS

• Educational Background: University degree (Bachelor's / BSc / BEng) in Engineering, Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• Professional Experience: Minimum 2+ years of relevant technical or supply chain experience associated with material qualification, new product/material introduction, or technical transfer within a pharmaceutical or biopharmaceutical environment.
• System & Technical Proficiency: Hands-on experience with SAP (specifically Master Data and Production Execution modules) and advanced competency in MS Office (especially Excel).
• Documentation & Regulatory Knowledge: Proven track record in document management, technical writing, and navigating GMP/regulatory frameworks. Deep understanding of single-use materials and applicable qualification standards is highly preferred.
• Soft Skills & Mindset: Proactive mindset with a strong sense of urgency, excellent communication skills across internal/external stakeholders, strong collaboration abilities, and an enterprise-driven approach to continuous process improvement.

eTeam Workforce sp. z o.o. is an employment agency entered into the register maintained by the Marshal of the Mazovian Voivodeship under number 21300.