Sr/Principal Computer Systems Validation Specialist

Location: Durham, North Carolina, United States; regular site presence required

Salary: $118,000–$162,800 for Senior; $133,000–$183,700 for Principal, annually

Company

hirify.global is a contract development and manufacturing organization providing regulated biopharmaceutical development and manufacturing services.

What you will do

• Provide global oversight and strategic direction for enterprise software validation.
• Guide, review, and approve validation lifecycle deliverables for enterprise software projects.
• Manage validation managed services for associated projects.
• Review and approve enterprise software change controls, CAPAs, and deviations.
• Support global data integrity initiatives and contribute to IT policies, SOPs, and validation templates.
• Partner with Quality Validation to ensure software validation complies with cGMPs, legal and regulatory requirements, and internal standards.

Requirements

• BS or MS degree with 8+ years of experience for Senior or 15+ years for Principal in computer systems validation within a cGMP environment.
• Demonstrated career growth and accomplishments in a computer systems validation role.
• Experience with data integrity and IT quality in an FDA-regulated manufacturing environment.
• Expert knowledge of 21 CFR Part 11, EU Annex 11, and current regulatory guidance on data integrity.
• Regular presence at the Durham, NC site is required.

Culture & Benefits

• Annual bonus structure for employees.
• Medical, dental, and vision coverage.
• Paid PTO and holidays.
• Sabbatical program.
• 401(k) matching with 100% vesting in 60 days.
• Employee recognition programs.