Senior Quality Engineer
12/20/2025
The Senior Quality Engineer will act as the Subject Matter Expert for media systems and manage GxP-compliant documentation. They will also investigate deviations, lead CAPA processes, and support cross-functional teams.
Working Hours
40 hours/week
Company Size
501-1,000 employees
Language
English
Visa Sponsorship
No
About Us: Valneva
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
About the Role
Valneva is looking for a driven Senior Quality Engineer to join our Engineering team in Solna. As our go-to expert for media systems—including Water for Injection, pure steam, and compressed air, you’ll ensure our technical documentation is top-notch and fully GxP-compliant. You’ll lead improvements, resolve deviations, and drive change control, all while supporting cross-functional teams and training colleagues. If you thrive on technical challenges and want to make a real impact in a fast-paced, life sciences environment, we want to hear from you.
Key Responsibilities
- Act as Subject Matter Expert (SME) for media systems (Water for Injection, pure steam, compressed air)
- Manage GxP-compliant documentation for media systems, monitoring equipment, reference instruments, and maintenance activities
- Investigate and resolve deviations; lead and document Corrective and Preventive Actions (CAPA)
- Oversee and execute change control processes
- Conduct equipment qualifications and system commissioning
- Perform risk assessments for systems and processes
- Periodically review technical documentation and departmental systems
- Train employees on new or updated procedures
- Administer maintenance and monitoring systems and provide system support for Engineering and other departments
- Write and maintain technical documentation
- Support planning and execution of activities in cross-functional teams
- Propose and lead improvements and small projects; escalate facility-related risks
- Review calibration certificates for Engineering
- Minimum 5 years’ experience in a similar role within a GxP-regulated environment
- Demonstrated experience in deviation handling, CAPA, and change control processes
- Familiarity with calibration, qualification, and commissioning of systems and equipment
- Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, or Industrial), Life Sciences (Biotechnology, Biochemistry, or Pharmaceutical Sciences), or Quality Management/Regulatory Affairs with a technical focus
- Strong technical knowledge of media systems (e.g., Water for Injection, pure steam, compressed air)
- Proficiency in developing and managing technical documentation
- Excellent communication and training delivery skills
- Ability to collaborate cross-functionally and lead continuous improvement initiatives
- Proficiency in Microsoft Office tools
- GxP or GMP certification, project management training (e.g., Lean Six Sigma, PMP), and hands-on experience with validation, calibration, and commissioning processes are considered assets
Employment & Benefits
Permanent position with a 6-month probation period.
As an employee at Valneva, you will benefit from several perks that support both your health and your development:
- Competitive salary under the applicable Swedish collective agreement
- Access to occupational health services
- Wellness allowance
- Vaccinations and reimbursement for medical visits and prescription medicines
- ITP occupational pension
- Eligibility for bonus and stock option programs
How to Apply / Questions
Selection and interviews are ongoing—please submit your application as soon as possible.
Questions? Contact HR: amy.gudjonsson@valneva.com.
Please note: We respectfully decline contact from recruitment and staffing agencies or suppliers.
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