Associate Validation Engineer – GDP Customer Qualification and Distribution Validation Cork, Ireland Hybrid

Job description

Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Location BioMarin, Shanbally, Co. Cork, Ireland Function Global Supply Chain / Global Distribution Job level Associate / Early Career Professional Employment type Full-time – 12 month contract Reporting line Manager, Cold Chain Logistics and Good Distribution Practice (proposed) Work arrangement Site-based or hybrid, subject to BioMarin policy and business requirements 1. Position Summary The Associate Validation Engineer supports the compliant qualification, approval, maintenance and offboarding of BioMarin customers and distribution partners. The role executes documented bona fide and technical capability assessments, coordinates cross-functional qualification activities, maintains controlled records, and supports distribution-validation work required to demonstrate that customers are legally authorised and technically capable of receiving, storing and distributing BioMarin medicinal products. The role will support customer-facing and distribution-readiness activities, particularly where customer facilities, receiving processes, transport lanes, monitoring controls or qualified thermal packaging interfaces must be assessed. Final customer approval, quality approval and Responsible Person accountabilities remain with the designated authorised approvers. 2. Key Responsibilities 2.1 Customer Qualification and Bona Fide Verification Perform and document initial and periodic bona fide checks for wholesale distributors, hospitals, pharmacies, government agencies, special-program customers and API customers within the assigned scope. Verify legal entity names, Sold-To, Ship-To and product storage addresses against customer intake information, ERP/SAP records, licences and competent-authority sources. Obtain, review and reconcile applicable WDA, MIA, GDP, GMP, hospital, pharmacy or API authorisations, including original-language records and EudraGMDP or MHRA-GMDP evidence where applicable. Confirm that authorised activities, addresses and product categories match the proposed BioMarin supply model. Escalate discrepancies, unverifiable credentials, suspected non-compliance, suspended or revoked licences, and product-category mismatches. Create and revise Bona Fide records using the approved template and naming conventions; compile attachments, evidence, translations and verification records; route records in Veeva QualityDocs for review and approval. Complete annual customer reviews, monitor licence and certificate expiry, obtain renewals, document no-expiry checks and support immediate customer holds or escalation when authorisation is no longer valid. Maintain traceable customer qualification records and support updates to approved customer lists and associated SAP GTS licence data in coordination with the relevant process owners. 2.2 Wholesale Distributor Onboarding and Change Management Coordinate qualification workstreams for new wholesale distributors and changes to existing distributors, including audit assessment, lane assessment, Quality and Technical Agreement, country specification, Technical Capability Assessment, Bona Fide and customer-list updates. Prepare or support change controls for customer introduction, address changes, product-category changes, Marketing Authorisation Holder changes, Responsible Person changes and other relevant supply-flow changes. Track actions, dependencies, approvals and evidence to completion before recommending closure of customer qualification activities. Support customer offboarding through controlled retirement of Bona Fide records, customer-list updates, ERP/GTS blocks, obsolete lane assessments and agreements, and documented stakeholder communication. Participate in Distribution Management governance meetings and provide clear status, risk, ageing and escalation updates. 2.3 Technical Capability and Distribution Validation Support issue, review and follow-up of Distributor GDP and Technical Capability Assessments in accordance with WI-109515 and applicable customer qualification change controls. Assess customer and distributor capability for receipt, temperature-controlled storage, environmental monitoring, alarm response, handling, pick/pack, shipping, business continuity, security, subcontractor oversight, recall and traceability. Identify gaps requiring evidence, remediation, quality risk assessment, audit follow-up, procedural controls or formal approval before supply. For customer or lane interfaces involving qualified thermal packaging, confirm relevant requirements are defined for temperature range, duration, shipping and receiving regions, payload, storage and conditioning, monitoring, replenishment, handling and business continuity. Support review of customer or third-party qualification evidence, protocols, reports, risk assessments and shipment performance data, while ensuring required Global Validation and Quality approvals are obtained. Contribute to continued suitability reviews using temperature-monitoring results, deviations, transportation trends, customer complaints and distribution performance information. 2.4 Quality Systems and Compliance Work in accordance with GDP, applicable GMP principles, data-integrity expectations, Good Documentation Practices and BioMarin Quality Management System requirements. Initiate or support deviations, investigations, CAPAs, change controls and quality risk assessments associated with customer qualification and distribution validation. Ensure records are complete, accurate, attributable, legible, contemporaneous, original and accurate, with appropriate review and approval in validated systems. Support regulatory inspections, internal audits and customer or service-provider audits by retrieving evidence, explaining process controls and managing assigned responses. Escalate compliance, patient-supply, product-quality or data-integrity risks promptly to the process owner, Quality and RP/DRP, as applicable. 2.5 Stakeholder and Project Coordination Collaborate with Global Distribution, Cold Chain Logistics, Global Validation, IMDQ, RP/DRP, Audit Compliance, Market Entry/Commercial, Order Fulfilment, Master Data, Regulatory, Pharmacovigilance, Legal/ABAC and external customers or logistics providers. Communicate requirements and evidence gaps professionally across dif