GMP Commissioning & Qualification Engineer - Biopharma

As an Engineer Commissioning & Qualification, you will play an important role in ensuring that equipment, utilities and computerized systems across our Thörishaus site are commissioned, qualified and validated in a compliant and robust way. Working closely with cross‑functional teams and external partners, you will act as a primary technical point of contact for C&Q topics and help ensure that our systems meet GMP and regulatory requirements from day one.

• Project Execution:
  Plan, coordinate, and execute assigned commissioning, qualification, and validation activities (IQ, OQ, PQ) in alignment with project schedules and milestones
• Direct Involvement in
  
  Qualifications:
  
  Personally conduct and supervise the execution of qualification tests to guarantee compliance with design specifications and regulatory requirements
• Documentation Management:
  Prepare, review, and maintain high‑quality C&Q documentation such as protocols, reports, deviation records, and traceability matrices
• Regulatory Compliance:
  Ensure all C&Q activities comply with applicable GMP, GxP, and regulatory requirements (e.g. EU GMP, FDA) and are always inspection‑ready
• Continuous Improvement:
  Contribute to the continuous improvement of C&Q processes, templates, and standards to enhance efficiency, compliance, and inspection readiness
• Cross‑functional
  
  Collaboration:
  
  Collaborate with Engineering, Quality, Manufacturing, Automation, and external suppliers to support effective and aligned execution of C&Q activities

• Degree (university or university of applied sciences) in chemical, mechanical or process engineering, biotechnology, pharmaceutical technology, chemistry or a comparable field or significant professional experience in the biopharmaceutical industry under GMP
• 3–5 years of hands‑on C&Q experience in a GMP biopharmaceutical environment
• Strong hands‑on experience with autoclave qualification and load qualification (load pattern definition, heat distribution and penetration studies)
• Strong knowledge of commissioning, qualification and validation principles and regulatory requirements (EU GMP Annex 15, FDA guidelines; Annex 11 / 21 CFR Part 11 and GAMP 5 are an advantage)
• Proven experience in deviation management, root cause analysis and CAPA
• Fluent English, written and spoken. German is a plus
• Proactive, resilient and reliable team player with strong decision‑making skills, a high sense of responsibility, and a structured, independent working style

• A small, close‑knit team in Thörishaus built on mutual support and healthy challenge.
• A flexible, collaborative way of working focused on the best solutions for our internal customers.
• The chance to be part of an international company with exceptional technology and a dedicated, agile Engineering team.
• A dynamic environment that supports your personal and professional growth.

Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America.

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.

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