Sr. Computer Systems Validation Specialist (Biotech)

Location: USA - NC - Durham - Hamlin Rd

Company

hirify.global operates a biopharmaceutical manufacturing facility requiring compliant validation of laboratory, manufacturing, and IT computer systems.

What you will do

• Execute and document the Computer Systems Validation program at the Durham facility.
• Prepare and maintain validation plans, risk assessments, functional requirements, configuration specifications, test documentation, change controls, traceability matrices, qualification protocols, and compliance reviews.
• Plan and contribute to CSV activities for laboratory and manufacturing systems.
• Track project deadlines, prioritize work, manage escalations, and provide status updates to management, end users, and clients.
• Monitor regulatory trends, technologies, and requirements, and participate in regulatory and client audits.

Requirements

• Bachelor’s or master’s degree in engineering or information technology.
• 5–7 years of industry experience.
• Required experience with lab equipment validation and IT computer validation.
• Knowledge of biotech manufacturing gained in a cGMP facility.
• Project management capability with strong written, oral, mathematical, analytical, and communication skills.
• Ability to walk and stand during protocol execution and system evaluations, and to handle computer hardware when needed.

Culture & Benefits

• Full-time employment at the Durham facility.
• Work involves collaboration with management, coworkers, end users, clients, and external vendors.
• Role supports compliance with cGMP, GLP, GCP, 21 CFR Part 11, EU Annex 11, and data integrity requirements.