Software Engineer/Developer
Senior Validation & Qualification Engineer – 12354
Uppsala, Sweden
Onsite
Job Summary
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Posted Date
April 30, 2025
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Work Type
Onsite
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Deadline
2025-05-07
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Schedule
Full-time
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Location
Uppsala, Sweden
Job Description
This post is also available in: Svenska (Swedish)
Assignment Description:
We are looking for a Senior Validation & Qualification Engineer to join our dynamic team.
What you will work on:
- Plan, execute, and report validation and qualification activities in compliance with regulatory requirements
- Lead and manage Change Control processes for equipment, systems, and facilities
- Collaborate with subject matter experts (SMEs) across multiple departments to ensure alignment and compliance
- Author and maintain User Requirement Specifications (URS)
- Write and execute qualification documents including protocols and reports using a risk-based approach
- Prepare and implement equipment relocation protocols to ensure qualified status is maintained
- Perform hands-on qualification activities such as temperature mapping of temperature-controlled units and areas
- Develop and update quality documentation including SOPs, instructions, and templates
- Manage quality-related tasks including deviations (DEV) and corrective and preventive actions (CAPA)
What you bring:
- Solid knowledge and practical experience in validation and qualification principles
- Strong skills in technical documentation with a high level of accuracy and attention to detail
- Excellent written and verbal communication skills
- Demonstrated ability to work collaboratively across cross-functional teams
- Service-minded and proactive approach with a focus on continuous improvement
- University degree in engineering, natural sciences, or a related technical field
- Minimum 2–3 years of experience in a GxP-regulated environment or other regulated setting in a validation or similar role
If this sounds interesting, please send your CV to cv@veritaz.se
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