Find Computer system validation engineer Jobs

Senior CSV Engineer
PM Group —Cork, County Cork
- Manufacturing
- SDLC
5d
Director, Software Engineering
Mastercard —Dublin, County Dublin
- Full-time
- Computer Science
- Bachelor's degree
- No degree
12d
Senior Electrical Engineer
IPS-Integrated Project Services —DUBLIN 12, County Dublin
- Full-time
- AutoCAD
- Engineering
- Bachelor's degree
ESSGraduate Engineer
ESS Ltd. —Limerick, County Limerick
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
1h
ESSGraduate Engineer
ESS LTD —Limerick, County Limerick
- €30,000–€35,000 a year
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
2h
Associate Process Engineer
Kneat —Limerick, County Limerick
- Full-time
- Engineering
- Project management
- Communication skills
2h

Other jobs to consider

Find your next job by exploring related positions.

Manufacturing Applications Developer & Database Specialist (EBR / MES)
Computeq —Castlebar, County Mayo
Work with production and QA colleagues on-site to turn their needs into practical, reliable applications. Proven experience developing and supporting database-…
€36,600–€55,156 a year
Quick apply
Fullstack Developer - Python
Citco —Dublin, County Dublin
Development in multiple modules and architectures, according to development best practices and current development technologies. AG Grid (Advanced Data Grids).

I want to receive the latest job alerts for computer system validation engineer

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

computer system validation engineer jobs near

Process Engineer jobs in Limerick, County Limerick

Senior Engineer jobs in Cork, County Cork

Engineer jobs in Limerick, County Limerick

Process Engineer jobs in Waterford, County Waterford

Bms Engineer jobs in County Dublin

Process Engineer jobs in County Cork

Automation Engineer jobs in Galway, County Galway

Process Technician jobs in Cork, County Cork

Data Engineer jobs in Dublin, County Dublin

Senior Engineer jobs in Kildare, County Kildare

Senior Engineer jobs in Galway, County Galway

Cloud Engineer jobs in Dublin, County Dublin

Civil Engineer jobs in Dublin, County Dublin

Test Automation Engineer jobs in Dublin, County Dublin

Security Engineer jobs in Dublin, County Dublin

Civil Engineer jobs in Limerick, County Limerick

Graduate Software Engineer jobs in Dublin, County Dublin

Fire Safety Engineer jobs in Dublin, County Dublin

Electrical Design Engineer jobs in Dublin, County Dublin

Firmware Engineer jobs in Dublin, County Dublin

Senior CSV Engineer

PM Group -
Cork, County Cork

Apply Now

Job details

5 days ago

Qualifications

Manufacturing
SDLC

Full job description

Responsible for Computer System Validation activities within a pharmaceutical manufacturing environment.

Responsible for the development and execution of key validation and quality documentation including Qualification Plans, Test Plans, Requirements Traceability Matrices (RTMs), and Validation Summary Reports, ensuring full compliance with GMP, GAMP5, and regulatory standards.

Worked closely with Automation, IT, Quality, and third-party vendors to support delivery of digital manufacturing systems and ensure alignment with project validation strategies and quality requirements.

Represented the CSV function at project, automation, and IT meetings while supporting overall project execution and compliance objectives.

Key Responsibilities

Delivered full Computer System Validation (CSV) lifecycle activities for SynTQ Syncade, including development and execution of test scripts, validation protocols, and Requirements Traceability Matrices (RTM) covering recipe management, electronic batch records (EBR), and manufacturing workflows.
Led validation of MES configurations, master data, audit trails, and electronic signatures in line with GMP, GAMP5, and 21 CFR Part 11 requirements, ensuring full data integrity and regulatory compliance.
Coordinated FAT/SAT and system acceptance testing for MES implementations and upgrades, including end-to-end integration with automation systems and resolution of validation deviations in collaboration with vendors and site teams.
Developed and maintained Qualification Plans and Validation Test Plans aligned with overall C&Q strategy.
Created and managed SDLC validation templates and documentation including:
User & Functional Requirements Specifications (URS/FRS)
Design Specifications
Requirements Traceability Matrices (RTM)
Code Review Documentation
Test Scripts & Test Specifications
Validation Summary Reports
Ensured all validation deliverables complied with internal quality standards and regulatory requirements.
Worked closely with Digital Data & Quality teams to ensure data integrity and compliance expectations were achieved.
Provided FAT oversight and performed leveraging assessments for vendor-supplied systems.
Supported project scheduling, validation tracking, and document management activities.
Collaborated with suppliers, system integrators, and project stakeholders to ensure adherence to validation standards and project timelines.
Supported project meetings and coordinated communication between Automation, IT, Quality, and Engineering teams regarding validation activities.

We are interested hearing from engineers with

5+ years’ experience in Computer System Validation within pharmaceutical or life sciences manufacturing environments
Expert knowledge of GAMP5 methodology
GMP & Regulatory Compliance
SDLC Documentation & Validation Lifecycle
FAT/SAT Oversight
Requirements Traceability Matrix (RTM)
Validation Planning & Execution
Vendor & Stakeholder Management
Data Integrity & Quality Compliance

Apply Now

Refine Your Search

computer system validation engineer jobs

Senior CSV Engineer

Director, Software Engineering

Senior Electrical Engineer

ESSGraduate Engineer

ESSGraduate Engineer

Associate Process Engineer

Other jobs to consider

I want to receive the latest job alerts for computer system validation engineer

Related Searches

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected