Associate Validation Engineer - GDP Customer Qualification and Distribution Validation

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 different markets, languages and regulatory frameworks.
- Maintain action trackers, qualification plans, decision logs and concise management updates.
- Support continuous improvement, standardised templates, metrics, workload forecasting and process simplification without weakening compliance controls.

3. Education and Experience

Essential

- Bachelor's degree in engineering, science, pharmacy, quality, supply chain or a related technical discipline.
- Practical experience in a regulated pharmaceutical, biotechnology, medical-device or healthcare distribution environment. Graduate or co-operative placement experience may be considered for an entry-level appointment.
- Working knowledge of validation or qualification principles, controlled documentation, deviations, CAPA, change control and risk management.
- Ability to review licences, technical records and objective evidence against defined requirements and document a clear, defensible conclusion.
- Strong written English, attention to detail, organisation and ability to coordinate multiple time-sensitive records.

Desirable

- Experience in GDP customer, supplier, distributor, 3PL or 4PL qualification.
- Experience with cold-chain distribution, thermal packaging, transport-lane risk assessments, temperature monitoring or shipping qualification.
- Familiarity with Veeva QualityDocs, SAP, SAP GTS, electronic change control and validated quality systems.
- Knowledge of EU GDP, EudraGMDP, MHRA-GMDP, Annex 15, ISTA or ASTM transport-testing principles.
- Experience supporting audits or inspections and working with international competent-authority records.

4. Technical Competencies

Competency

Expected capability

Customer qualification

Bona fide review; licence and address reconciliation; product-category verification; customer onboarding, maintenance and offboarding.

Validation and qualification

Requirements review; evidence assessment; protocol/report review; acceptance criteria; traceability; risk-based justification; lifecycle thinking.

GDP and cold chain

Temperature-controlled storage and transport; monitoring; excursion controls; qualified packaging interfaces; lane and receiving risks.

Quality systems

GDP/GMP documentation; deviations; CAPA; change control; risk management; audit readiness; data integrity.

Systems and records

Veeva QualityDocs/EDMS, SAP/ERP and SAP GTS awareness; controlled trackers; electronic records and metadata accuracy.

Analytical skills

Identify gaps, inconsistencies and compliance risk; distinguish evidence from assertion; make proportionate recommendations.

Communication

Clear technical writing; professional customer follow-up; cross-functional coordination; concise escalation and status reporting.

5. Behavioural Expectations

- Quality mindset: protects product quality, patient safety and licence compliance when balancing speed and supply needs.
- Ownership: follows actions through to evidence-based closure and raises constraints early.
- Judgement: applies procedures consistently, recognises when escalation or expert input is required, and avoids approving beyond delegated authority.
- Collaboration: works constructively across Quality, Supply Chain, Commercial and external partners.
- Precision: produces inspection-ready records with strong version, attachment, metadata and reference control.
- Continuous improvement: identifies recurring failure modes and proposes practical, compliant improvements.

6. Role Outputs and Performance Measures

Performance measures should be agreed through BioMarin goal-setting and should not override quality decisions. Suitable measures include:

- Timely completion of assigned new-customer, change and annual-review records.
- Right-first-time quality of Bona Fide, TCA, change-control and supporting evidence packages.
- No customer release recommended without required authorisation, product-category alignment and approvals.
- Timely escalation of suspended, revoked, expired or unverifiable licences and other critical gaps.
- On-time closure of assigned deviations, CAPAs and audit actions.
- Accuracy of customer lists, qualification trackers and handoffs to ERP/SAP GTS process owners.
- Effective stakeholder communication and reduction in avoidable rework.

7. Decision Rights and Boundaries

- The role may prepare assessments, identify evidence gaps, coordinate remediation and make documented recommendations within approved procedures.
- The role does not replace the approval responsibilities of the BioMarin RP/DRP, IMDQ, Global Validation, QA, Audit Compliance, Regulatory or designated change-control approvers.
- Customer supply must not be recommended where required licences, authorised activities, addresses, product categories or approvals are missing, expired, suspended, revoked or materially inconsistent.
- Any conflict between commercial timing and GDP or validation requirements must be escalated through the applicable Quality and Supply Chain governance process.

8. Working Conditions

- Based at BioMarin Shanbally, Co. Cork, with interaction across global time zones.
- Routine computer and document-review work in validated enterprise systems.
- Occasional travel to customer, distributor, warehouse, test-laboratory or service-provider sites may be required, subject to business need.
- Participation in audit, inspection or urgent licence-risk responses may occasionally require schedule flexibility.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.