Senior CSV Engineer

Location: Hybrid, based at a client site in Tipperary, Ireland

Company

hirify.global delivers large-scale engineering and biotech capital projects, including commissioning, qualification, and validation services.

What you will do

• Commission and qualify hardware and associated software supporting utility and process equipment.
• Work with PLC, SCADA, and network interfaces during automation validation.
• Prepare commissioning, qualification, and verification protocols for process equipment CSV.
• Execute commissioning, installation qualification, operational qualification, and verification activities in the field.
• Coordinate and review vendor automation packages to streamline CSV delivery.
• Manage people involved in project activities.

Requirements

• 7+ years of full-lifecycle CSV experience at intermediate to senior level.
• CSV experience with process equipment such as filling lines, freeze dryers, vial washers, tunnels, cappers, autoclaves, parts washers, and storage vessels.
• Strong knowledge of GAMP5, 21 CFR Part 11, Annex 11, and modern CQV/CSV practices.
• Experience with software and automation validation in a project environment.
• Degree-level qualification in engineering, science, or a related field.
• Excellent spoken and written English is required.

Culture & Benefits

• Hybrid work with activities performed at a client site.
• Hands-on involvement in large-scale biotech capital projects.
• Work across varied commissioning, qualification, and validation activities.