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

Senior Validation Engineer
Alexion Pharmaceuticals,Inc. —Dublin, County Dublin
- Engineering
- Assembly
- Project management
12d
Product Lifecycle Electrical Engineer, Data Center Engineering - Electrical Products and Services (DCE-EPS)
Amazon Data Services Ireland Limited —Dublin, County Dublin
- Full-time
- AWS
- Bachelor's degree
- Continuous improvement
6d
Automation Engineer
Ipsen Manufacturing Ireland Ltd —Dublin, County Dublin
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
12d
Principal Silicon Validation Engineer
Qorvo —DUBLIN 8, County Dublin
- Engineering
- Data analysis skills
- Analysis skills
4d
Senior Process Engineer - Packaging
Embecta —Dún Laoghaire, County Dublin
- Full-time
- Engineering
- Data analysis skills
- Bachelor's degree
IT Associate
CBTax —Dublin, County Dublin
- Software troubleshooting
- IT
- Communication skills
Quick apply
Biopharma Production Specialist
Avantor —Dublin, County Dublin
- Full-time
- Manufacturing
Senior CAD Technician (Cork/ Dublin)
Jacobs —Dublin, County Dublin
- Hybrid work
- AutoCAD
- CAD
Project Manager
Sisk —Dublin, County Dublin
- Full-time
- Contracts
- Construction experience
- Communication skills
- Annual leave
14d
Senior Mechanical Engineer
Mercury Engineering —Dublin, County Dublin
- Construction experience
Senior Engineer; Bridges & Structures (Dublin / Cork)
Jacobs —Dublin, County Dublin
- Hybrid work
- Civil Engineering
- Communication skills
Civil Engineer Detailed Design - (Dublin, Cork)
Jacobs —Dublin, County Dublin
- Hybrid work
- Leadership
- Communication skills
Senior Electrical Engineer
Mercury Engineering —Dublin, County Dublin
- Construction experience
CSA Quantity Surveyor (Belgium)
PM Group —Dublin, County Dublin
- Full-time
- English
- Bachelor's degree
- Contracts
Environmental, Health and Safety Manager
CEL - Critical Power —Dublin, County Dublin
- Full-time
- Leadership
- Communication skills
Quick apply
Senior Electrical Design Engineer
Mercury Engineering —Blanchardstown, County Dublin
- Construction experience
Civil Design Engineer
Mercury Engineering —Blanchardstown, County Dublin
- Construction experience
Staff Quality Engineer II
BD —Dublin, County Dublin
- €75,900–€115,725 a year
- Engineering
- Analysis skills
- Project management
10d
Senior Quality Engineer - Validation
West Pharmaceutical Services —Dublin, County Dublin
- €65,208–€82,992 a year
- Engineering
- Manufacturing
- Communication skills
12d
Project Engineer
West Pharmaceutical Services —Dublin, County Dublin
- €51,040–€64,960 a year
- Overtime
- Engineering
- Microsoft Office
- Project management
14d

I want to receive the latest job alerts for sr. manufacturing engineer process quality, hardware engineering manufacturing in dublin, d

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

sr. manufacturing engineer process quality, hardware engineering manufacturing jobs near dublin, d

Bridge Engineer jobs in Dublin, County Dublin

Senior Validation Engineer jobs in Dublin, County Dublin

Project Engineer jobs in Dublin, County Dublin

Quantity Surveyor jobs in Dublin, County Dublin

Senior Mechanical Engineer jobs in Dublin, County Dublin

Automation Engineer jobs in Dublin, County Dublin

Electrical Engineer jobs in Dublin, County Dublin

Senior Electrical Engineer jobs in Dublin, County Dublin

Senior Quality Engineer jobs in Dublin, County Dublin

CAD Technician jobs in Dublin, County Dublin

Project Manager jobs in Dublin, County Dublin

Bridge Engineer jobs in Cork, County Cork

Quality Engineer jobs in Limerick, County Limerick

It Support Engineer jobs in Dublin, County Dublin

Project Engineer jobs in Cork, County Cork

Qa Automation Engineer jobs in Dublin, County Dublin

Project Engineer jobs in Carnmore Cross Roads, County Galway

Project Engineer jobs in Limerick, County Limerick

Project Coordinator jobs in Dublin, County Dublin

Quantity Surveyor jobs in Milford, County Carlow

Senior Validation Engineer

Alexion Pharmaceuticals,Inc. -
Dublin, County Dublin

Apply Now

Job details

12 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, d

Senior Validation Engineer

Product Lifecycle Electrical Engineer, Data Center Engineering - Electrical Products and Services (DCE-EPS)

Automation Engineer

Principal Silicon Validation Engineer

Senior Process Engineer - Packaging

IT Associate

Biopharma Production Specialist

Senior CAD Technician (Cork/ Dublin)

Project Manager

Senior Mechanical Engineer

Senior Engineer; Bridges & Structures (Dublin / Cork)

Civil Engineer Detailed Design - (Dublin, Cork)

Senior Electrical Engineer

CSA Quantity Surveyor (Belgium)

Environmental, Health and Safety Manager

Senior Electrical Design Engineer

Civil Design Engineer

Staff Quality Engineer II

Senior Quality Engineer - Validation

Project Engineer

I want to receive the latest job alerts for sr. manufacturing engineer process quality, hardware engineering manufacturing in dublin, d

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected