Lead CSV Engineer (Biotech)

Location: Hybrid, Cork, Ireland, based at a client site

Company

hirify.global delivers engineering and project services for large-scale biotech projects.

What you will do

• Commission and qualify hardware and associated software supporting utility and process equipment, including PLC, SCADA, and network interfaces.
• Prepare commissioning, qualification, and verification protocols for process equipment CSV.
• Execute field commissioning, installation and operational qualification, and verification for process equipment automation, including clean and black utilities.
• Coordinate and review vendor automation packages to streamline CSV activities.
• Manage people and contribute across varied large capital projects.

Requirements

• Lead CSV experience covering the full lifecycle.
• CSV experience with process equipment such as filling lines, freeze dryers/lyophilizers, vial washers and 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 or a science-related field.
• Hands-on attitude and experience with functional testing of the specified equipment.
• Excellent oral and written communication skills in English.
• High level of customer orientation and understanding.

Culture & Benefits

• Contract position with a hybrid working arrangement.
• Work with a highly skilled hirify.global team on large-scale biotech projects.
• Role based at a client site in Cork, Ireland.