Join us in Bern as we launch a new production site and introduce new ways of working. Here, you help ensure high quality standards and support the delivery of safe and effective pharmaceutical products. You get the chance to shape how we work and grow, whether you are experienced, coming from academia, or a related industry. Be part of our determined team and make an impact in a vibrant, adaptable work environment that supports your personal and professional growth.
Your tasks
- Develop, review, and approve CSV and QV strategies, plans, protocols, and reports for new and existing facilities, utilities, equipment, and computerized systems
- Work with teams like Engineering, Manufacturing, IT, and other Quality services to ensure compliance and timely project delivery
- Take part in audits and inspections related to CSV and QV, making sure documentation is ready and robust
- Promote a culture of quality, compliance, and continuous improvement within CSV and QV activities, and mentor team members and stakeholders
- Support changes and corrections related to CSV and QV
- Act as the subject matter expert (SME) for regulations and guidelines, including EU GMP (EudraLex Volume 4, Annex 11 and 15) and FDA 21 CFR Part 11
What you bring
- University degree in engineering, life sciences, computer science, or a related field
- At least 5 years of experience in CSV and ideally QV within pharmaceutical, biotechnology, or a related regulated industry
- Experience in QA is a plus
- Proven ability to lead and coordinate complex validation projects with multiple teams
- Strong knowledge of cGMP, GAMP, FDA, EMA, and other relevant regulations and guidelines
- Excellent technical writing, problem-solving, and project management skills
- Very good written and spoken English skills; German is an advantage
- Strong interpersonal and communication skills
What we offer
- Be part of an international company with exceptional technology
- Work in a vibrant and adaptable environment
- Grow your personal and professional skills
- Join a determined and enthusiastic team
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Über uns
Bavarian Nordic is a global vaccine company focused on improving health and saving lives through innovative vaccines. We are a leading supplier of mpox and smallpox vaccines to governments and offer a strong portfolio of travel vaccines. Headquartered in Denmark, we have manufacturing, research, and sales offices across Europe and North America. We are committed to equal opportunity and a welcoming workplace for everyone.