MES CSV Engineer

MES Computer Systems Validation (CSV) Engineer - Pharmaceutical Manufacturing

Location: Kinsale, Cork, Ireland

Contract: Initial 24 months

24-Month Contract | Major Pharmaceutical MES Deployment | Cork

TechNET IT Recruitment is supporting one of the world's largest pharmaceutical organisations with a major Manufacturing Execution System (MES) deployment programme at its Kinsale manufacturing facility.

We are looking for an experienced MES Computer Systems Validation (CSV) Engineer to support validation and compliance activities throughout the implementation.

This is an excellent opportunity for a CSV professional with MES experience to contribute to a significant digital manufacturing transformation within a highly regulated pharmaceutical environment.

The Role

You will support Computer Systems Validation activities associated with the deployment of a Manufacturing Execution System, ensuring that systems are appropriately tested, documented and validated in accordance with applicable regulatory and quality requirements.

Working closely with MES engineers, quality assurance, validation and manufacturing stakeholders, you will help ensure the successful delivery of a compliant and production-ready system.

Key Responsibilities

• Support Computer Systems Validation activities throughout the MES implementation lifecycle.
• Prepare, review and execute validation documentation and associated test protocols.
• Support validation planning, test execution and evidence collection.
• Identify, document and support the resolution of defects and validation issues.
• Work closely with MES engineers, QA, IT and manufacturing stakeholders.
• Maintain accurate validation records and supporting documentation.
• Support system readiness and validation activities ahead of deployment.
• Ensure validation activities align with applicable GMP, GxP and regulatory requirements.

Essential Experience

• Proven experience in Computer Systems Validation (CSV) within regulated environments.
• Previous experience working with Manufacturing Execution Systems (MES).
• Strong understanding of validation documentation, testing and compliance requirements.
• Experience supporting computerised system implementation or validation projects.
• Excellent documentation, problem-solving and stakeholder communication skills.
• Ability to work collaboratively with technical, quality and manufacturing teams.

Desirable Experience

• Pharmaceutical or biotechnology manufacturing experience.
• Knowledge of GAMP5, GMP/GxP and 21 CFR Part 11.
• Experience with MES platforms such as Emerson Syncade, Werum PAS-X, Siemens Opcenter or similar.
• Experience supporting MES deployment, upgrades or system validation projects.

Please note: Emerson Syncade experience is not essential for this position. Candidates with CSV experience across other MES platforms are strongly encouraged to apply.

Please apply directly or contact me to discuss the opportunity in more detail.