Validation Engineer

Location: Hybrid/Remote in the United States, reporting into an office in Pennsylvania or North Carolina; hybrid workers attend the office 2 days per week.

Company

hirify.global and its d-wise business design, deploy, and support validated cloud infrastructure and statistical computing environments for life-sciences and clinical trial organizations.

What you will do

• Plan, organize, execute, and report validation exercises for internal and external clients.
• Assess risks, analyze faults and deviations, and plan resolution and mitigation activities.
• Define and evolve risk-based validation methodologies, standards, and work instructions.
• Design, develop, and maintain automated validation tests and frameworks suitable for GxP environments.
• Create and maintain UAT scripts, test evidence packages, workflow documentation, templates, and validation support materials.
• Collaborate with Development, QA, Product teams, clients, and auditors to align validation with the software development lifecycle and regulatory expectations.

Requirements

• Experience validating computer and software systems in a GxP environment.
• Knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5, or comparable industry standards.
• Familiarity with Azure DevOps or similar application lifecycle management tools.
• Demonstrable process-improvement experience, ideally in a regulated environment.
• Good knowledge of Microsoft Office products.

Nice to have

• Experience with test automation tools such as Selenium or Playwright.
• Scripting experience with Python or PowerShell.

Culture & Benefits

• Permanent position with flexible hybrid/remote working and a one-off home-working allowance.
• Medical, dental, vision, life, short-term and long-term disability insurance.
• 401(k) matching plan, flexible spending account, and health savings account.
• 15 days of vacation, public holidays, and a vacation buy-and-sell scheme.
• Personal and technical development opportunities in a solutions-focused global business.