Validation Engineer / Validation Engineeress

Join Us in Our Mission to Improve Lives

At Bavarian Nordic, our goal is to enhance and save lives by harnessing the power of the immune system. Our portfolio of commercial products includes leading vaccines against mpox, rabies, tick-borne encephalitis, typhoid fever, cholera, and chikungunya. We excel in research and development, manufacturing, and commercialization, always striving to improve health and quality of life for people globally. Join us as we make a significant impact.

Position Available: Validation Engineer in MSAT (f/m/d)

We are seeking to strengthen our Manufacturing, Science and Technology (MSAT) Validation Team with the addition of a Validation Engineer. This role focuses on process, cleaning, and shipping validation for biotechnological products, including the oversight of Process Performance Qualification (PPQ) campaigns and commercial production. You will lead technical investigations, provide support to Manufacturing Support Engineers, and ensure ongoing process verification.

Key Responsibilities

• Perform all functions associated with process, cleaning, and shipping validation, including defining validation strategy, planning, writing of plans/protocols, execution support, data evaluation, and report writing.
• Author and lead process risk analysis while defining process control strategies.
• Act as a Validation Subject Matter Expert (SME) on global project teams and validation councils.
• Support internal teams as a Validation SME, including investigation and project teams.
• Author and support deviations/investigations and change controls in manufacturing.
• Recommend and lead process changes to the larger process team through implementation of respective change controls.
• Conduct process monitoring (control charts) and statistical process analysis, including authoring continued process verification reports (CPV).
• Contribute data, analyses, write-ups, reviews, and other input to annual Product Quality Reviews (PQR).
• Participate in internal, customer, and regulatory inspections.
• Support Technology Transfer projects as either a receiving or sending process SME.
• Drive initiatives for Operational Excellence and Environmental Health and Safety improvements.

About You

• Bachelor's degree or higher in Life Sciences.
• Highly autonomous and self-initiated.
• Excellent written (especially technical writing) and verbal communication skills in both German and English.
• Experience in mid and large-scale process and cleaning validation within the GMP-regulated Life Science industry (preferably Biotech) is a plus.
• Experience in cell culture, downstream processing, and aseptic manufacturing is beneficial.

We offer you the chance to be part of an international company known for its exceptional technology and a dedicated team. If you share our enthusiasm and desire to create a meaningful impact, consider joining our dynamic MSAT team. Expect a vibrant and adaptable work environment that fosters the growth of your personal and technical skills, alongside a competitive compensation and benefits package.

Ready to Join Us?

If this opportunity aligns with your career goals, we would love to hear from you. Apply online using the form below. Please note that only applications matching the job profile will be considered.

Founded in 1994, Bavarian Nordic has over 30 years of experience in developing life-saving vaccines and is a global leader in smallpox and mpox vaccines. Our headquarters are in Denmark, with manufacturing, research, and sales offices across Europe and North America. We embrace change, foster teamwork, and prioritize the protection of lives every day. If these values resonate with you, we invite you to become a part of Bavarian Nordic!

Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment without discrimination based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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