Computer System Validation Engineer

Role overview

The Computer System Validation Engineer will support validation and compliance work for IT solutions being introduced into a continuous manufacturing environment. This role focuses on ensuring newly implemented digital and IT systems are validated correctly and meet applicable quality expectations.

You will be part of a collaborative team and should be comfortable working independently when needed. Strong communication and interpersonal abilities are important, along with experience in a regulated or pharmaceutical API manufacturing setting being a plus.

Key responsibilities

• Own the validation lifecycle for IT projects, from software installation through to business release.
• Plan, monitor, report on, and track CSV activities, documentation progress, and key performance indicators.
• Work with service providers and internal IT staff to confirm software is installed correctly and configured as required.
• Prepare validation documents in line with site procedures and GMP standards.
• Run test scripts, review outcomes, and judge whether results meet the predefined acceptance criteria.
• Partner with the business to define and apply procedural controls where testing identifies risks or issues.
• Raise and drive change control activities in line with quality requirements.
• Recommend practical solutions and improvements where changes are needed.
• Sequence validation work according to project timelines and priorities.
• Coordinate with global IT and Quality groups.
• Influence delivery through other parties such as contract system integrators and internal engineering teams.

Required experience and background

• At least 5 years of experience delivering IT solutions, integrating systems, supporting applications, and validating IT applications and interfaces.
• Hands-on experience creating validation plans, gathering requirements, producing design documents, configuring systems, testing, and troubleshooting.
• Working knowledge of 21 CFR Part 11, electronic records/electronic signatures, and data integrity principles.
• Exposure to data analytics and reporting solutions would be an added advantage.
• Clear verbal and written communication skills, with the ability to build effective cross-functional relationships.
• A self-directed, detail-focused approach with strong organization and time-management capability.
• Good interpersonal skills and the ability to work effectively with different stakeholders.
• Experience with Emerson Syncade MES, Veeva QualityDocs, and Kneat, including hardware and software test planning plus document creation and execution, is desirable.

Additional information

This position is based in the Limerick Metropolitan Area and is an on-site contract role.