CSV Validation Engineer | Computer Systems & Automation Validation – Vilnius

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

About Thermo Fisher Scientific

At Thermo Fisher Scientific, we develop solutions that help people live healthier, cleaner, and safer lives. This is more than our mission—it is the impact our colleagues make every day.

At our Vilnius site, we develop and manufacture innovative life science and diagnostic technologies used by researchers, clinicians, and laboratories around the world. Our teams work with advanced manufacturing, laboratory, automation, and quality systems that support reliable operations and high-quality products.

Join a collaborative environment where technology, quality, compliance, and continuous improvement come together to support products used globally.

Job Overview

We are looking for a CSV Validation Engineer to join our team and support computerized systems and automation validation activities across manufacturing, laboratory, quality, and technical environments.

In this role, you will work at the intersection of technology, quality, automation, and regulated operations. You will help validate computerized and automated systems that support manufacturing, laboratories, quality processes, and product delivery, ensuring they are reliable, compliant, and fit for intended use.

You will support validation throughout the system lifecycle — from requirements, risk assessment, testing, and documentation to deviation management, change control, periodic review, and ongoing compliance.

Previous job title does not need to be “CSV Engineer”. We welcome candidates from validation, automation, IT systems, quality, laboratory systems, engineering, or regulated manufacturing backgrounds who want to grow in computerized systems validation.

This is a great opportunity to build expertise in Computerized Systems Validation (CSV), GAMP5 principles, data integrity, and GMP compliance while working in a growing international life sciences organization.

You will collaborate closely with Quality, IT, Automation, Engineering, Manufacturing, Laboratory Operations, and Technical Operations teams.

Key Responsibilities

• Plan, coordinate, and execute computerized systems validation activities

• Support validation of systems used in manufacturing, laboratory, quality, automation, and technical operations

• Prepare, review, and execute validation documentation, including requirements, risk assessments, test protocols, reports, procedures, and related records

• Support system lifecycle activities, including system implementation, changes, periodic reviews, and decommissioning

• Apply GAMP5, GMP, data integrity, and applicable regulatory principles to validation activities

• Identify, document, and investigate deviations related to validation execution

• Support corrective and preventive actions to ensure timely and effective issue resolution

• Collaborate with IT, Automation, Quality, Manufacturing, Engineering, and Laboratory teams

• Act as a point of contact for computerized systems validation activities with internal stakeholders

• Support continuous improvement initiatives related to CSV processes, documentation, testing, and compliance

• Coordinate external vendors or technical specialists during validation activities when required

Experience and Qualifications

• Advanced degree in Engineering, Life Sciences, Chemistry, Biotechnology, Information Technology, Automation, Computer Science, or another related technical field

or

• Bachelor’s degree with at least 2 years of relevant experience in validation, quality, IT systems, automation, engineering, manufacturing, laboratory operations, or another regulated environment

• Experience in GMP, ISO, pharmaceutical, biotechnology, medical device, diagnostics, laboratory, manufacturing, automation, or another regulated technical environment would be an advantage

• Experience with systems, software, automation, quality documentation, validation, testing, or technical project work would be beneficial

Skills and Competencies

• Interest in computerized systems validation, system qualification, automation, or regulated technical processes

• Strong technical writing skills and ability to prepare clear, structured documentation

• Analytical thinking and structured problem-solving skills

• Ability to work with data, identify risks, and support evidence-based decisions

• Good understanding of documentation, traceability, testing, and change control principles

• Strong organizational skills and ability to manage several priorities at once

• Good communication skills and ability to collaborate with technical and non-technical teams

• Proficiency in Microsoft Office tools

• Good written and spoken English skills

• Ability to work in regulated production or laboratory environments when required

Preferred Qualifications

• Experience with Computerized Systems Validation (CSV)

• Knowledge of GAMP5, GMP, ISO, FDA regulations, data integrity, or electronic records principles

• Experience with automation systems, LIMS, MES, ERP, QMS, SCADA, PLC, or laboratory software

• Experience with validation or testing in GMP or another regulated environment

• Experience with IQ/OQ/PQ, system testing, risk assessment, or gap analysis

• Knowledge of quality management systems and regulated documentation practices

• Experience managing validation or technical projects independently

• Knowledge of statistical analysis, process control, or data analysis tools

What We Offer

• Annual performance bonus and additional financial benefits

• Comprehensive health package, including private health, life and accident insurance

• Wellbeing support for employees and their family members, including mental health consultations, health check-ups, vaccinations, and on-site health initiatives

• Opportunities for professional growth through internal training, access to Thermo Fisher e-University, and continuous development

• The opportunity to work in a global, innovation-driven organization and collaborate with international teams

• Daily benefits such as subsidized meals, gym access, and company transportation

• An inclusive and supportive culture, with team events and community initiatives

• 2 additional paid volunteering days per year

We are an equal opportunity employer and value diversity. All qualified applicants will receive consideration regardless of race, religion, gender, age, disability, veteran status, sexual orientation, gender identity, or any other protected characteristic.

How to Apply

If you are interested in computerized systems validation, automation, quality, technology, and continuous improvement — and want to grow your career in a global life sciences organization — we would love to hear from you.

Even if your experience covers only part of the CSV field, but you are motivated to learn and develop in this area, we encourage you to apply.

Compensation

The monthly salary range estimated for this position based in Lithuania is €2 183,33–€3 270,83.