Find Implementation engineer Jobs in Limerick, Lk

CSV Engineer
PM Group —Limerick, County Limerick
- Manufacturing
- SDLC
Senior Mechanical Engineer
DPS Group —Limerick, County Limerick
- Engineering
- Bachelor's degree
- Leadership
4d
Mixed-Signal Design Engineer
Analog Devices —Limerick, County Limerick
- Full-time
- Master's degree
- Bachelor's degree
- Electrical Engineering
Graduate Electronics Engineer
AARON PCB —Shannon, County Clare
- €30,000–€32,000 a year
Quick apply
1d
Lead Engineer, Product Marketing
Analog Devices —Limerick, County Limerick
- Full-time
- Sales
- Electrical Engineering
- Marketing
Mixed Signal Design Engineer
Analog Devices —Limerick, County Limerick
- Full-time
- Master's degree
- Bachelor's degree
- Electrical Engineering
Hydrogeologist
Egis —Limerick, County Limerick
- Master's degree
- Bachelor's degree
- In-person
8d
Senior COHE / LOTO Engineer
CAI —Limerick, County Limerick
- Full-time
- Engineering
- Communication skills
Quick apply
Director, Analog Design
onsemi —Limerick, County Limerick
- Full-time
- Bachelor's degree
- Recruiting
- Electrical Engineering

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Senior Mechanical Engineer
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CSV Engineer

PM Group -
Limerick, County Limerick

Apply Now

Job details

Qualifications

Manufacturing
SDLC

Full job description

Role Overview

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.

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.

Technical Skills & Experience

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

implementation engineer jobs in limerick, lk

CSV Engineer

Senior Mechanical Engineer

Mixed-Signal Design Engineer

Graduate Electronics Engineer

Lead Engineer, Product Marketing

Mixed Signal Design Engineer

Hydrogeologist

Senior COHE / LOTO Engineer

Director, Analog Design

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