Senior Computer System Validation Engineer (f/m/d)

Job Description

For us, it is all about improving and saving lives

In Bern, we’re not just expanding-we’re reaching a major milestone by launching a new production site and introducing innovative ways of working. This is what being a Persistent Pioneer in our BN DNA is all about-bringing a pioneering spirit to everything we do. Whether you’re an experienced professional, transitioning from academia, or coming from a related industry, you’ll have the unique opportunity to influence how we work and grow.

We are looking to strengthen the Engineering Team with a

Senior Computer System Validation Engineer (f/m/d)

Our engineering department is a close-knit team of more than 30 employees that covers all engineering aspects in-house. We operate like a family, supporting each other, and are composed of regional and international specialists. Our team communicates in both German and English. Continuous development is in our DNA, as is the goal to achieve something extraordinary.

Main accountabilities:

• Review and approve CSV and OT-related system lifecycle design documentation (user requirements, functional and design specifications, data flow diagrams, commissioning, and qualification protocols).
• Performs cycle driven tasks including Computerized System Periodic Review, Data Integrity Assessment and Risk/Gap assessments and mitigation activities
• Commissioning and qualification of software, spreadsheets and computerized equipment
• Deviation Investigation, Change Control and CAPA Management: Lead Projects, site changes and Risk Management activities related to CSV
• Provides customer focus supporting engineering, research and development, quality, manufacturing sciences and technology, and manufacturing as a Subject Matter Expert for CSV topics.

Your Educational Background and professional expertise

• BS/MSc in IT, Computer Science or equivalent with a strong track record in Biotech-Industry.
• Professional Experience: Minimum of 5 years of experience in CSV related field, with project management experience.
• Languages: English, oral and written, German is a plus.

Expected technical competencies:

• Technical / Lifecycle Documentation: Creation/execution of CSV deliverable packages including URS, FDS, HDS, Commissioning, Qualification Protocols/Reports, data flow diagrams, Periodic Review Reports, Data Integrity Assessment and Risk/GAP Assessment Reports
• System Validation: commissioning and qualification of software, spreadsheets and computerized equipment/systems
• Project Management: Demonstrate ability to lead and manage CSV and OT projects, ensuring coordination with stakeholders and adherence to timelines and budgets
• Regulatory Knowledge: Comprehensive understanding of GMP, FDA, GAMP5 and other relevant regulatory guidelines
• Audit participation experience

We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and professional skills.

Are you ready to join us in our mission?

If this sounds like the next step in your career, we would love to hear from you. Simply click the «APPLY» button on the right side of the page and you will be redirected to our application form. We are conducting interviews on an ongoing basis and encourage you to apply as soon as possible.

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

We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position.

Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
www.bavarian-nordic.com

Bavarian Nordic