Engineer Comissioning & Qualification (f/m/d)

Global Vaccine Innovation and Public Health Preparedness

Join a global vaccine company dedicated to improving health and saving lives through innovative solutions. As a preferred supplier of mpox and smallpox vaccines to governments, we enhance public health preparedness while maintaining a leading portfolio of travel vaccines. Headquartered in Denmark, our operations span manufacturing, research, and sales offices across Europe and North America.

Role Overview

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

Key Responsibilities

• 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.

Qualifications and Experience

• 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.

What We Offer

• 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.