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Senior Validation Engineer

Alexion Pharmaceuticals,Inc. -
Dublin, County Dublin

Apply Now

Job details

11 days ago

Qualifications

Vendor management
Engineering
Minitab
Assembly
Six Sigma
Project management
Bachelor's degree
Continuous improvement
Packaging
Manufacturing
Leadership
Communication skills
ISO 13485

Full job description

Location: Dublin, Ireland Job reference: R-256867 Date posted: 07/22/2026

Introduction to role:

Are you ready to lead validation that makes advanced packaging and combination product assembly reliable, scalable, and audit-ready—so life-changing medicines reach patients sooner? Do you want your expertise to turn capital investments and new product introductions into safe, compliant, and right‑first‑time operations?

Based at our College Park site in Dublin, you will be the validation subject matter expert for packaging and combination product assembly manufacturing. You will shape and execute the validation strategy using a risk-based verification approach, ensuring robust, efficient qualification of new lines, technologies, and process improvements. Partnering closely with Quality, Operations, Automation, Device Design, and Engineering, you will connect technical excellence to tangible outcomes for patients and the business.

Accountabilities:-Risk-Based Verification Leadership: Define and apply the RBV approach to determine validation requirements for new equipment, new products, and improvements—focusing effort where risk is highest to protect patients and accelerate delivery.-Validation Documentation Excellence: Draft, review, approve, and execute Test Plans, Risk Assessments (including FMEAs), Protocols, Data Integrity Assessments, and Validation Summary Reports that stand up to regulatory scrutiny.-Capital Projects and NPI Delivery: Lead validation workstreams on major capital projects and new product introductions, ensuring on-time, compliant start-up of packaging and assembly operations that enable reliable supply.-Vendor Engagement (FAT/SAT): Lead vendor FAT and SAT execution, drive issue resolution at source, and provide clear progress updates to internal stakeholders to de-risk commissioning and qualification.-Audit and Inspection Readiness: Serve as the validation SME for packaging and combination assembly during regulatory audits, articulating strategy, evidence, and outcomes with clarity and confidence.-Cross-Functional Influence: Represent Validation across stakeholder groups, aligning requirements, unlocking decisions, and coaching teams on risk-based thinking to improve speed, quality, and compliance.-Continuous Improvement and Data Use: Apply statistical tools and digital validation platforms to analyze results, identify root causes, and implement corrective actions that improve process capability and reduce rework.

Essential Skills/Experience:-Bachelor's degree (or higher) in Engineering/Life Sciences preferred-4 - 7 years of experience in validation/qualification of packaging systems or combination products within the pharmaceutical, medical device industry- Experience in risk-based validation approach- Experience in issue description, root cause identification, technical/quality impact assessment and corrective action justification- Proficiency in statistical tools (e.g., Minitab), risk management methodologies (FMEA, ISO 14971)- Statistical knowledge for Process Validation- Problem solver with a focus on achievement of overall project goals- Experience in using digital Validation e.g. Kneat

Regulatory Knowledge: Working knowledge of regulatory requirements and standards

-Cross-Functional Collaboration: Proven ability to collaborate effectively with stakeholders- Project Management skills-Good organization and planning skills-Ability to meet challenging schedules and deal with technical issues-Ability to work independently and remotely with minimum direct supervision-Strong leadership and communication skills

Desirable Skills/Experience:- Experience with packaging line technologies such as automated assembly, robotics, vision systems, labeling, and serialization/aggregation- Familiarity with ISO 13485, 21 CFR Part 4/820, EU MDR and related combination product guidance- Hands-on execution of URS development, IQ/OQ/PQ, and design transfer for combination products- Design of Experiments, SPC, and advanced data analysis to inform validation strategy- Exposure to MES/SCADA/PLC integration and automation impact on validation- Lean Six Sigma certification or equivalent continuous improvement experience- Vendor management and contract manufacturing partner oversight for validation activities- Leadership in data integrity practices (e.g., ALCOA+) within validation programs

Why AstraZeneca:Here, purpose and practical impact meet. You will work where scientists, engineers, and quality experts sit together to test ideas, challenge assumptions, and unlock bold thinking—then turn it into safe, compliant manufacturing that serves people living with rare and devastating diseases. You will have access to modern technologies in packaging and combination product assembly, digital validation tools, and a community that values kindness alongside ambition. Diversity of thought is encouraged, inclusion is championed, and your growth is supported with real ownership and trust—so the validation strategies you design today become the reliable therapies patients count on tomorrow.

Call to Action:Lead the validation that powers dependable launches for patients who need them most—take the next step in your career with purpose and apply today.

Date Posted

22-Jul-2026

Closing Date

04-Aug-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

Apply Now

Refine Your Search

sr. manufacturing engineer process quality, hardware engineering manufacturing jobs in dunboyne, mh

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