Computer Systems Validation Engineer

The Innopharma Group; Limerick; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Innopharma Group in Ireland seeks a Computer Systems Validation Engineer to validate computer systems and coordinate compliance activities for a multinational manufacturing client in Co. Limerick.

The role emphasizes formal validation documentation, process automation and IT infrastructure qualification under GMP standards, with strong writing and collaboration requirements.

Qualifications

• Minimum BS/BA in Engineering, Chemistry or Life Sciences.
• 3+ years in Automation and IT infrastructure qualification/validation.
• GMP environment experience is essential.
• Strong technical writing and documentation skills.
• Excellent communication and collaboration abilities.

Responsibilities

• Prepares and reviews validation documentation for projects and change controls.
• Manages change controls, non-conformances and compliance tasks.
• Reviews and updates CSV procedures and policies.
• Analyzes test results against acceptance criteria for compliance.
• Investigates and recommends solutions to issues.
• Coordinates validation activities with internal teams and contractors.

Skills

Automation

CSV / Computer Systems Validation

Documentation

Regulatory compliance

Test analysis

Collaboration

Education

BS/BA in Engineering

BS/BA in Chemistry

Life Sciences

Tools

Microsoft Project

Job description

Innopharma Technical Services, part of Innopharma Group, specializes in the training and employment of highly skilled, project ready, Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.

Are you ready to take the next step in your career within a leading biopharma environment?

We are now seeking a Computer Systems Validation Engineer to join our team to provide support in validation/qualification activities to our Multinational Manufacturing client based in Co. Limerick.

About the position:

This position uses policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems. Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.

Key responsibilities:

• Prepares and reviews validation documentation for projects and change controls.
• Manages change controls, non-conformances, and other compliance-related tasks.
• Reviews and contributes to current and future CSV procedures and policies.
• Analyses test results against acceptance criteria to determine compliance.
• Investigates, troubleshoots, and recommends solutions or improvements.
• Identifies current and future compliance requirements and proposes methods for implementing and maintaining necessary procedures, actions, and documentation.
• Coordinates validation activities with internal departments and external vendors/contractors.
• Supports regulatory audits and communicates company computer validation policies.
• Assesses computer systems for Part 11 and Annex 11 compliance gaps.
• Manages projects and prepares progress reports using Microsoft Project and other tools.
• Supervises, leads, or manages junior personnel as required.

Preferred Experience:

• Minimum BS/BA in Engineering, Chemistry, or Life Sciences is required.
• 3+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation is desired; will substitute relevant experience for education.
• Experience in a GMP environment is essential.
• Strong technical writing and documentation skills.
• Excellent communication and collaboration skills.
• A proactive, detail-focused approach with a passion for continuous improvement.

Note:

• Due to the nature of the business, additional duties may be required from time to time.
• All applicants must be eligible to work in Ireland without sponsorship

INNOPHARMA, RAVENSCOURT BUSINESS PARK, THREE ROCK RD, SANDYFORD, DUBLIN 18, D18 K599, IRELAND