Senior Computer Systems Validation Specialist (Biopharma)

Location: Durham, North Carolina, United States

Company

hirify.global provides biopharmaceutical development and manufacturing services.

What you will do

• Support all stages of the Computer Systems Validation lifecycle and ensure systems remain qualified for intended use.
• Author validation protocols, test scripts, data tables, procedures, and summary reports.
• Execute validation activities, analyze and verify data, assess acceptance criteria, and resolve deviations.
• Track regulatory changes and implement processes supporting 21 CFR Part 11, EU Annex 11, and data integrity requirements.
• Maintain the validation documentation archive and respond to internal, external, and auditor requests.
• Coordinate validation support for change controls, deviations, CAPAs, and audit observations.

Requirements

• Bachelor’s degree in Engineering or Information Technology; a master’s degree is strongly preferred.
• Seven or more years of experience as a CSV Specialist or in a related pharmaceutical or biotechnology role.
• At least seven years of experience with GAMP, 21 CFR Part 11, software functional testing, regulatory guidance, validation principles, and equipment control software.
• Experience with CSV lifecycle documentation, system risk assessments, protocol development and execution, deviation resolution, and final report closure.
• Strong technical writing, communication, data analysis, problem-solving, organization, and project coordination skills.
• Ability to support audits, lead and train Validation employees, interpret technical documentation, and work independently or collaboratively.

Culture & Benefits

• Full-time employment in a regulated biopharmaceutical environment.
• Work includes collaboration with internal stakeholders, auditors, and validation teams.
• Role requires meeting physical requirements, including lifting up to 25 pounds.