Senior Quality Engineer at Valneva

Solna, Stockholm County, Sweden -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

0.0

Posted On

21 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, GxP Compliance, Media Systems, Deviation Handling, CAPA, Change Control, Equipment Qualification, Risk Assessment, Technical Documentation, Training Delivery, Cross-Functional Collaboration, Continuous Improvement, Microsoft Office, Validation, Calibration, Commissioning

Industry

Biotechnology Research

Description

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.

Responsibilities

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.