Senior Quality Engineer

Solna , Sweden
full-time

AI overview

Lead media systems improvements and ensure GxP compliance, collaborating with cross-functional teams to deliver exceptional quality in vaccine development.

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

Requirements

  • 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

Benefits

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: [email protected].

Please note: We respectfully decline contact from recruitment and staffing agencies or suppliers.

Perks & Benefits Extracted with AI

  • Occupational pension: ITP occupational pension

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. We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines. Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.

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