SDLC Validation Lead (Biotech)

TL;DR

SDLC Validation Lead (Biotech): Leading the commissioning and qualification of hardware and software for biotech process equipment with an accent on CSV, GAMP5, and regulatory compliance. Focus on designing and executing IQ/OQ/PV protocols, coordinating vendor automation packages, and managing the full CSV lifecycle for high-scale capex projects.

Location: Hybrid (Dublin, Ireland)

Company

hirify.global is a professional services firm specializing in the delivery of large-scale biotech and pharmaceutical projects.

What you will do

• Perform commissioning and qualification of hardware and associated software for utility and process equipment, including PLC, SCADA, and network interfaces.
• Prepare Commissioning, Qualification, and Verification (CQV) protocols for process equipment CSV.
• Execute field-based Installation and Operational Qualification (IQ/OQ) and verification for automation and utilities.
• Coordinate and review vendor automation packages to streamline CSV processes.
• Manage personnel and project activities within a large-scale capex environment.

Requirements

• 7+ years of experience in full-lifecycle Computer System Validation (CSV).
• Experience with process equipment such as filling lines, freeze dryers, autoclaves, and storage vessels.
• Deep knowledge of GAMP5, 21 CFR Part 11, and Annex 11 regulations.
• Background in software/automation validation within project-based environments.
• Degree in Engineering or a Science-related field.
• Must be based in or able to work in a hybrid capacity in Dublin, Ireland.

Culture & Benefits

• Opportunity to work on high-impact, large-scale Biotech projects.
• Collaboration with highly skilled engineering teams.
• Dynamic project environment with a high degree of variety in daily activities.
• Professional growth within a globally recognized project management group.