Validation Analyst (Medtech)

TL;DR

Validation Analyst (Medtech): Ensuring clinical data systems and test devices for Precision Motion, Respiratory, and Cardiac business lines comply with industry standards and regulatory requirements with an accent on documentation and compliance. Focus on executing test reports, managing deviations, and ensuring system functionality meets intended use requirements.

Location: Onsite in Estenfeld, Germany

Company

hirify.global, part of Thermo Fisher Scientific, focuses on unlocking better evidence to transform lives and bring life-changing therapies to patients faster.

What you will do

• Write comprehensive validation documentation including Test Strategies, Test Reports, and Traceability matrices.
• Evaluate systems and configurations to ensure compliance with industry standards and regulatory requirements.
• Document, communicate, and track test deviations and associated corrective actions.
• Collaborate with in-house development and operational staff to define system specifications.
• Support the Quality Assurance department during client audits through documentation and system demonstrations.
• Execute test reports and perform ongoing quality reviews of clinical data systems.

Requirements

• Bachelor's Degree in Computer Science, IT, Health/Life Sciences, Biomedical Engineering or equivalent work experience.
• Minimum 1 year experience in a validation role or related job experience.
• Knowledge of GCPs, 21CFR Part 11, and electronic record requirements is desired.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Excellent organizational and communication skills with high attention to detail.

Culture & Benefits

• Flexible working hours and working time accounts to support work-life balance.
• Professional development via internal and external training and certification programs.
• Modern office with an on-site canteen offering local and vegetarian dishes.
• Company pension scheme and competitive salary.
• Deutschlandticket for public transport users and free on-site parking.
• Active social and wellness committees organizing events and activities.