Computer System Validation Coordinator

TL;DR

Computer System Validation Coordinator (CSV): Coordinating and supporting Computer System Validation activities across Global Sales with an accent on maintaining the Validation Master Plan (VMP), tracking validation and periodic review status, and ensuring ongoing compliance. Focus on providing SME guidance to SSUs, improving CSV procedures and documentation, and supporting audits and global QMS-related projects.

Company

hirify.global provides hospitals and life science institutions with life-saving technology and solutions.

What you will do

• Coordinate and oversee Computer System Validation (CSV) activities within Global Sales, aligned with QMS requirements and global standards.
• Maintain, update, and support execution of the Global Sales Validation Master Plan (VMP) with SSUs.
• Build and maintain an up-to-date inventory of computerized systems used across Global Sales.
• Monitor, track, and follow up validation and system periodic review status, ensuring outcomes and actions are documented and closed.
• Provide SME guidance to SSUs for validation, periodic review execution, and compliant retirement of computerized systems via CSV procedures.
• Review and continuously improve CSV procedures, work instructions, and templates; support harmonized CSV documentation practices and participate in audits and global projects.

Requirements

• Location: Remote role based in Turkey, Poland, or the Czech Republic (up to 10% travel to office).
• Bachelor’s degree in Engineering, Life Sciences, Information Systems, or related field.
• Minimum 3–4 years of experience in Computer System Validation or Quality roles in a regulated industry.
• Experience working with computerized system validation in a global or cross-functional environment.
• Solid understanding of global CSV regulatory expectations, including international standards and guidelines (e.g., ISO 13485, GAMP 5) and applying them to validation, periodic reviews, and audit readiness.

Culture & Benefits

• Health, Dental, and Vision insurance benefits.
• Pension plan with company match.
• Paid Time Off, wellness initiative, and health assistance resources.
• Life insurance, short- and long-term disability benefits, and flexible spending accounts.
• Parental and caregiver leave, tuition reimbursement, and commuter benefits.

Hiring process

• Application submission via hirify.global careers portal.
• Selection process for qualified candidates with equal opportunity consideration.

Location: Remote (Turkey/Poland/Czech Republic), up to 10% travel to office