Computer System Validation Coordinator

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Title: Computer System Validation Coordinator

Location - Remote role based in Turkey/Poland/Czech Republic with up to 10% travel to office

Job Overview

The Computer System Validation (CSV) Coordinator - Global Sales is responsible for coordinating and supporting Computer System Validation activities across Global Sales.

The role ensures validated status and ongoing compliance of computerized systems by maintaining the Validation Master Plan (VMP), coordinating periodic reviews, updating CSV documentation, and providing SME guidance to SSUs.

The role is part of Global Sales QRC team, and operates in close matrix collaboration with the Group IT CSV organization, including participation in CSV forums, peer reviews, and alignment on standards and templates.

Job Responsibilities and Essential Duties

• Coordinate and oversee Computer System Validation (CSV) activities within Global Sales, ensuring alignment with QMS requirements and applicable global standards.
• Maintain, update, and support execution of the Global Sales Validation Master Plan (VMP) with SSUs.
• Establish and maintain an accurate and up-to-date inventory of computerized systems used across Global Sales.
• Monitor, track, and follow up validation and system periodic review status.
• Provide guidance to SSUs for execution of required validation and Periodic Review activities.
• Ensure outcomes, gaps, and actions from validation and periodic reviews are appropriately documented and followed up
• .Support SSUs for compliant and complete retirement of any computer systems via CSV procedures.
• Act as a Computer System Validation (CSV) Subject Matter Expert, providing practical guidance and support to SSUs on CSV validation and System Periodic Review activities.
• Develop and deliver CSV process trainings to SSUs to support consistent understanding and application of CSV requirements.

• Review, update, and continuously improve CSV procedures, work instructions, and templates to enhance usability, clarity, and Compliance to related standards and regulations.
• Support harmonized implementation of CSV documentation practices across Global Sales.

• Support global changes and projects impacting Global Sales computerized systems and the QMS (e.g., SAP GShape) from a Quality & Regulatory Compliance perspective.
• Participate in and support corporate and external audits related to Global Sales, including preparation, responses, and follow-up actions.
• Support, coordinate and handle any other project/task given by direct manager for Quality and Regulatory Compliance activities.
• Coordinate and support Global Sales activities related to the deployment of corporate quality systems, tools, and process changes, ensuring timely implementation, stakeholder alignment, and regulatory compliance.

Minimum Requirements

• • 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 within a regulated industry.
  • Experience working with computerized system validation in a global or cross-functional environment.
  • Solid understanding of global Computer System Validation regulatory expectations, including applicable international standards and guidelines (e.g. ISO 13485, GAMP 5, and related industry best practices), ability to apply these principles to validation, periodic reviews, and audit readiness activities.

Required Knowledge, Skills and Abilities

• • Expert on Computer System Validation lifecycle and System Periodic Reviews.
  • Strong knowledge of Quality Management Systems, ISO13485 and ISO9001, regulatory requirements for computerized systems.
  • Strong coordination, follow-up, and documentation skills.
  • Ability to provide clear guidance to stakeholders.
  • Strong communication skills and ability to work independently in a global role.

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• Health, Dental, and Vision insurance benefits
• Pension plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.