QA Specialist; f​/m​/d – CSV & QV

In Bern, we’re launching a new production site and introducing innovative ways of working. This role supports our mission of high‑quality pharmaceutical products.

• Develop, review and approve CSV and QV strategies, plans, protocols and reports for new and existing facilities, utilities, equipment, and computerized systems.
• Partner with cross‑functional teams such as Engineering, Manufacturing, IT, and other Quality services to ensure compliance and timely project execution.
• Participate in audits and inspections related to CSV and QV, ensuring readiness and robust documentation.
• Drive a culture of quality, compliance, and continuous improvement within CSV and QV activities, mentoring team members and stakeholders as needed.
• Support changes and corrections related to CSV and QV.
• Act as subject‑matter expert for relevant regulations and guidelines, including EU GMP (Eudra Lex Vol.
  4, Annex
  11 &15) and FDA 21
  
  CFRPart
  11.

• University degree in engineering, life sciences, computer science or a related field.
• Minimum 5years of experience in CSV and ideally QV within the pharmaceutical, biotechnology or related regulated industry; experience in QA is a plus.
• Demonstrated capability to drive and coordinate complex validation projects in a cross‑functional environment with multiple stakeholders.
• In‑depth knowledge of cGMP, GAMP, FDA, EMA and other relevant regulations and guidelines.
• Strong technical writing, problem‑solving, and project management skills.
• Excellent written and spoken English skills;
  German is an advantage.
• Strong interpersonal and communication abilities.

Opportunity to be part of an international company that boasts exceptional technology and a determined team. A vibrant and adaptable work environment supports the growth of personal and professional skills.

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.