Senior Computer System Validation Engineer / Senior Computer System Validation Engineeress

Join Our Mission to Improve and Save Lives

At Bavarian Nordic, we are reaching a significant milestone in Bern with the launch of a new production site and the introduction of innovative working methods. This embodies our spirit as Persistent Pioneers, driving us to excel in everything we do. Whether you're an experienced professional, transitioning from academia, or coming from a related industry, this is your chance to influence how we work and grow.

We Are Hiring: Senior Computer System Validation Engineer (f/m/d)

Parental Cover for 12 Months

Our engineering department consists of a close-knit team of over 30 dedicated employees, covering all engineering aspects in-house. We nurture a family-like atmosphere, providing support to one another, and our team is made up of both regional and international specialists. With communication conducted in both German and English, we thrive on continuous development and strive for excellence in all our endeavors.

Main Responsibilities

• Review and approve CSV and OT-related system lifecycle design documentation, including user requirements, functional and design specifications, data flow diagrams, and qualification protocols.
• Perform cycle-driven tasks, including Computerized System Periodic Review, Data Integrity Assessment, and risk/gap assessments and mitigation activities.
• Commission and qualify software, spreadsheets, and computerized equipment.
• Lead Projects related to deviation investigation, change control, and CAPA management, as well as risk management activities concerning CSV.
• Act as a Subject Matter Expert for CSV topics, providing support to engineering, research and development, quality, manufacturing sciences and technology, and manufacturing.

Your Educational Background and Professional Expertise

• BS/MSc in IT, Computer Science, or equivalent with strong experience in the Biotech Industry.
• Minimum of 5 years of professional experience in the CSV field, including project management experience.
• Fluency in English, both oral and written; proficiency in German is a plus.

Expected Technical Competencies

• Creation and execution of CSV deliverable packages, including URS, FDS, HDS, commissioning protocols/reports, and risk/gap assessment reports.
• Experience in commissioning and qualification of software, spreadsheets, and computerized systems.
• Proven project management skills, leading and managing CSV and OT projects with effective stakeholder coordination.
• Comprehensive knowledge of GMP, FDA, GAMP5, and other relevant regulatory guidelines.
• Experience participating in audits.

Join an international company that champions exceptional technology and a driven team. If you share our enthusiasm and desire to create a meaningful impact, we welcome you to apply online using the form below. Anticipate a vibrant and adaptable work environment that fosters both personal and professional growth.

Are You Ready to Join Us?

We look forward to receiving your motivated CV, briefly detailing your motivation for applying for this position. A cover letter is optional.

Only applications matching the job profile will be considered. We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.

Bavarian Nordic is a global vaccine company committed to enhancing health and saving lives through innovative vaccines. As a preferred supplier of mpox and smallpox vaccines to governments and with a leading portfolio of travel vaccines, we are headquartered in Denmark and have operations across Europe and North America.

Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment, free from discrimination based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

For more information, visit www.bavarian-nordic.com.