Find Csv engineer Jobs in Cashel County Tipperary

CSV Engineer
Horizon Controls Group —Tipperary, County Tipperary
- Computer Science
- Bachelor's degree
- Manufacturing
4d
Computer System Validation (CSV) Engineer
PACIV —Tipperary, County Tipperary
- Full-time
- Computer Science
- Engineering
- No degree
Quick apply
3d
Senior Engineer - DeltaV & CQV Support
Horizon Controls Group —Tipperary, County Tipperary
- Computer Science
- Engineering
- Bachelor's degree
12d
Senior DeltaV Commissioning Engineer
PACIV —Tipperary, County Tipperary
- Full-time
- ERP systems
- Maintenance
- No degree
Quick apply

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Senior DeltaV Commissioning Engineer
PACIV —Tipperary, County Tipperary
Applicants must be legally authorized to work in Ireland without current or future employer sponsorship. Lead and execute FAT, SAT, commissioning, startup, and…
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CSV Engineer

Horizon Controls Group -
Tipperary, County Tipperary

Apply Now

Job details

4 days ago

Qualifications

Computer Science
Bachelor's degree
Technical writing
Manufacturing
Communication skills
SDLC
Information Technology

Full job description

Engagement Summary

- Objective: Provide Computer System Validation (CSV) leadership and support for capital projects, ensuring all automated and computerized systems are implemented, qualified, and validated in compliance with quality standards, GAMP5, SDLC methodology, and applicable regulatory requirements.
- Engagement Type: Time-and-materials

Scope and Core Responsibilities

Serve as the Computer System Validation (CSV) Subject Matter Expert (SME) for capital projects.
Provide a standardized CSV approach across projects in alignment with the CSV Lead's validation strategy.
Work closely with Automation, IT, Quality, Engineering, and teams responsible for system delivery and implementation.
Collaborate with vendors, suppliers, and system integrators to ensure compliance with validation and quality requirements.
Develop and maintain Qualification Plans, Validation Plans, and Test Plans aligned with project Commissioning & Qualification (C&Q) strategies.
Develop, review, and approve Software Development Lifecycle (SDLC) deliverables, including:

ü Requirements Specifications

ü Functional Specifications

ü Design Specifications

ü Requirements Traceability Matrices (RTM)

ü Code Review Documentation

ü Test Specifications and Test Scripts

ü Validation Summary Reports

ü Other qualification and validation documentation as required

Ensure all CSV deliverables comply with quality procedures, GAMP5 guidance, SDLC requirements, and applicable regulatory standards.
Partner with Digital Data & Quality (DDQ) teams to ensure all data integrity and compliance requirements are addressed.
Review vendor documentation and validation packages to confirm compliance with standards and leveraging requirements.
Provide Factory Acceptance Testing (FAT) oversight and perform validation leveraging assessments.
Support project teams with CSV guidance, document generation, review, and execution activities.
Participate in project planning activities and provide input into realistic project schedules and validation trackers.
Represent the CSV function at project, automation, IT, quality, and stakeholder meetings.
Facilitate communication between project stakeholders regarding validation strategy, documentation, testing, and compliance requirements.
Support regulatory inspections, audits, and quality reviews as required.

Deliverables

Computer System Validation Plans (CSV Plans)
Qualification Plans and Test Plans
Requirements Specifications (URS/RS)
Functional Specifications (FS)
Design Specifications (DS)
Requirements Traceability Matrices (RTM)
Code Review Documentation
Test Specifications and Test Scripts
Validation Summary Reports
FAT Oversight Documentation and Leveraging Assessments
Vendor Compliance Review Reports
SDLC Templates and Validation Documentation Standards
Qualification and Validation Execution Records
Validation Schedules and Document Trackers
Risk Assessments and Compliance Assessments
Audit and Inspection Support Documentation
Project Status Reports and Stakeholder Updates
Final Validation Approval and Project Closeout Documentation

Required Qualifications and Competencies

Bachelor's Degree in Computer Science, Engineering, Automation, Information Technology, or related discipline.
Minimum 3 years of Computer System Validation experience within Life Sciences or Pharmaceutical Manufacturing.
Expert knowledge of GAMP5 validation methodology.
Strong understanding of SDLC processes and validation lifecycle requirements.
Experience developing and executing validation documentation within GMP-regulated environments.
Demonstrated experience reviewing and approving validation deliverables.
Experience working with vendors and system integrators on regulated projects.
Strong stakeholder management, communication, and technical writing skills.
Ability to operate effectively within cross-functional project teams.

Apply Now

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csv engineer jobs in cashel county tipperary

CSV Engineer

Computer System Validation (CSV) Engineer

Senior Engineer - DeltaV & CQV Support

Senior DeltaV Commissioning Engineer

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