We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
We have leveraged our expertise and capabilities both to commercialize three vaccines, including the world’s first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika.
With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health.
Together, we are a global Company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work.
Responsibilities
We are seeking an experienced IT System Engineer (m/f/d) with deep understanding of Gx P regulations to design, implement, and maintain IT systems in compliance with pharmaceutical industry standards. You will collaborate with cross-functional teams, including Quality Assurance, Quality Control, Manufacturing, and IT. On top of that your key responsibilities will be:
System Design and Validation

• Design, plan, and implement IT systems and infrastructure in accordance with Gx P regulations (GMP, GLP, GCP)
• Develop and execute validation protocols (IQ, OQ, PQ) for IT systems and software

System Maintenance and Support

• Monitor system performance and troubleshoot issues to ensure continuous operation
• Provide technical support for IT systems and software used in Gx P environments (software updates, patches, and backups, ...)

Quality and Compliance Management

• Conduct periodic reviews and audits of IT systems to ensure compliance with Gx P regulations
• Respond to quality incidents and implement corrective and preventive actions as necessary, including documentation for IT systems and processes in compliance with regulatory requirements
• Support our organization in Audits/Inspections performed by health care organizations

Security and Risk Management

• Implement and maintain security controls to protect IT systems and data in accordance
• Conduct risk assessments and develop risk mitigation strategies for IT systems
• Respond to security incidents and implement appropriate remediation measures and be up-to-date on industry trends and regulatory changes

Requirements

• Bachelor’s degree in computer science, Information Technology, or related field
• 3-5 years of experience in IT systems engineering or a similar role in the pharmaceutical industry
• IT System Admin or knowledge of LIMS, e MBR, Gen5, Chromeleon, Empower, Softmax Pro, ...
• Deep understanding of Gx P regulations and requirements (GMP, GLP, GCP)
• Experience with system validation, including validation protocols (IQ, OQ, PQ) and validation documentation
• Strong technical skills in server administration, virtualization, cloud management and networking
• Knowledge of IT security principles and practices in Gx P environments
• Excellent problem-solving skills and attention to detail
• Effective communication and interpersonal abilities

Benefits

• Open, appreciative company culture with innovative spirit and attractive assignments
• International surrounding with flat hierarchies
• Good team spirit in a strong and highly motivated team
• Wide range of benefits like flexitime, compensation days, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events, my Clubs, full access to Linked In Learning, ...

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 55.000,00 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.