Find Sr. manufacturing engineer process quality, hardware engineering manufacturing Jobs in Dublin 8, D

Senior Validation Engineer
Alexion Pharmaceuticals,Inc. —Dublin, County Dublin
- Engineering
- Assembly
- Project management
4d
Technology Operational Readiness Lead – Drug Product Manufacturing
PM Group —Dublin, County Dublin
- Manufacturing
- Leadership
- Communication skills
Senior Equipment Engineer - Packaging System Owner
Amgen —Dún Laoghaire, County Dublin
- €70,408.90–€95,259.10 a year
- Engineering
- Maintenance
- Bachelor's degree
Intermediate Process Engineer - Life Sciences
Jacobs —Dublin, County Dublin
- Hybrid work
- Communication skills
Mechanical Engineer
Applied Materials —Dublin, County Dublin
- Full-time
- CAD
- Engineering
- System design
Senior/Lead Process Design Engineer (EPCM)
DPS Group —Citywest, County Dublin
- Full-time
- Engineering
- System design
- Communication skills
Head of Supply Chain Transformation
Life Scientific —Dublin, County Dublin
- Hybrid work
- System design
- AI
Senior Mechanical Design Engineer
Manna —Dublin, County Dublin
- €70,000–€90,000 a year
- Full-time
- Hybrid work
- CAD
- Assembly
- Bachelor's degree
Quick apply
Senior Packaging Engineer
MSD —Leopardstown, County Dublin
- Full-time
- Hybrid work
- Engineering
- Analysis skills
- Project management
10d
Field Operations Lead
Indra Group UK & Ireland —Dublin, County Dublin
- Weekend availability
- Hybrid work
- Microsoft Office
- Analysis skills
- Recruiting
Quick apply
Senior Automation / OT Consultant
NNIT A/S —Dublin, County Dublin
- Azure
- English
- Java
Data Center – Physical Infrastructure Specialist
Abbott Laboratories —Dublin, County Dublin
- Full-time
- Bachelor's degree
- Electrical Engineering
Senior Engineer; Bridges & Structures (Dublin / Cork)
Jacobs —Dublin, County Dublin
- Hybrid work
- Civil Engineering
- Communication skills
10d
Senior Manager, Process Validation
West Pharmaceutical Services —Dublin, County Dublin
- €100,900–€130,200 a year
- Computer Science
- No degree
- Manufacturing
Senior Validation Engineer
AstraZeneca —Dublin, County Dublin
- Engineering
- Assembly
- Project management
4d
Lead/Senior Electrical Engineer - Life Sciences
Jacobs —Dublin, County Dublin
- Part-time
- Hybrid work
- System design
- Master's degree
- Electrical Engineering
Associate Director - Civil Engineering (Transmission & Distribution)
Jacobs —Dublin, County Dublin
- Hybrid work
- Civil Engineering
- Leadership
- Communication skills
11d
Senior Design Engineer
Sisk —Dublin, County Dublin
- Full-time
- AutoCAD
- Project management
- Construction experience
- Annual leave
Senior Electrical Engineer - Aviation
Sisk —Dublin, County Dublin
- Full-time
- Analysis skills
- Plumbing
- Mentoring
- Annual leave
Senior Project Manager - Modular Solutions
CEL - Critical Power —Dublin, County Dublin
- Full-time
- English
- Project management
- Electrical Engineering
Quick apply

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Senior Validation Engineer

Alexion Pharmaceuticals,Inc. -
Dublin, County Dublin

Apply Now

Job details

4 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 dublin 8, d

Senior Validation Engineer

Technology Operational Readiness Lead – Drug Product Manufacturing

Senior Equipment Engineer - Packaging System Owner

Intermediate Process Engineer - Life Sciences

Mechanical Engineer

Senior/Lead Process Design Engineer (EPCM)

Head of Supply Chain Transformation

Senior Mechanical Design Engineer

Senior Packaging Engineer

Field Operations Lead

Senior Automation / OT Consultant

Data Center – Physical Infrastructure Specialist

Senior Engineer; Bridges & Structures (Dublin / Cork)

Senior Manager, Process Validation

Senior Validation Engineer

Lead/Senior Electrical Engineer - Life Sciences

Associate Director - Civil Engineering (Transmission & Distribution)

Senior Design Engineer

Senior Electrical Engineer - Aviation

Senior Project Manager - Modular Solutions

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