Mid Level Automation CSV Engineer

Cork - Ireland

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

Role Overview:

The CSV Engineer will be responsible for ensuring that computerized systems used within

the organization comply with regulatory requirements and internal quality standards.

This role involves developing writing and executing Computer System Validation (CSV)

protocols managing documentation and supporting audits to maintain compliance with

GxP and other applicable regulations.

Key Responsibilities:

Develop and author CSV protocols including Installation Qualification (IQ)

Operational Qualification (OQ) on Kneat.

Execute validation protocols and document results in accordance with company

SOPs and regulatory guidelines via Kneat.

Perform risk assessments and impact analyses for computerized systems.

Ensure compliance with FDA EMA and GAMP 5 guidelines for system

validation.

Collaborate with Automation teams Quality and business stakeholders to

ensure systems meet user requirements and compliance standards.

Maintain validation documentation and ensure traceability throughout the

system lifecycle.

Support internal and external audits by providing validation evidence and

responding to queries.

Troubleshoot validation issues and propose corrective actions.

Participate in change control processes for validated systems.

Key Requirements:

Education: Bachelors degree in Computer Science Engineering Life Sciences

or related field.

Experience:

Minimum 2 years in Computer System Validation within a regulated

environment (pharmaceutical biotech or medical devices preferred).

Hands-on experience writing and executing validation protocols (IQ/OQ/) on

Kneat.

Technical Skills:

Strong understanding of GAMP 5 21 CFR Part 11 and Annex 11 compliance

requirements.

Familiarity with DeltaV PLC MES or other GxP systems.

Soft Skills:

Excellent documentation and communication skills.

Strong attention to detail and ability to work under strict timelines

Role Overview: The CSV Engineer will be responsible for ensuring that computerized systems used withinthe organization comply with regulatory requirements and internal quality standards.This role involves developing writing and executing Computer System Validation (CSV)protocols managing documentati...