Validation Engineer in MSAT (f/m/d)

À propos de cette offre

For us, it is all about improving and saving lives

At Bavarian Nordic, we are committed to saving and improving lives by unlocking the power of the immune system. Our commercial product portfolio includes market-leading vaccines against mpox, rabies, tick-borne encephalitis, typhoid fever, cholera, and chikungunya. We excel in R&D innovation, manufacturing, and commercialization, striving to improve health and quality of life for people worldwide, protecting our tomorrow. Join us in our mission to make a difference.

We are looking to strengthen the MSAT Validation Team with a Validation Engineer in MSAT (f/m/d).

About the role

The role within the Manufacturing, Science and Technology (MSAT) team focuses on process, cleaning and shipping validation for biotechnological products, including Process Performance Qualification (PPQ) campaigns and commercial production. It involves leading technical investigations, supporting Manufacturing Support Engineers and ensuring continued process verification.

Key responsibilities include validation planning and execution support, data collection and analysis, identification of trends, troubleshooting, process improvement and preparation of validation reports.

You will be part of the MSAT Validation Team, which brings a broad background and experience. The team is highly collaborative and open-minded with a great team spirit. Your primary workplace will be in Thörishaus (close to Bern) in a shared office space. We believe in flexibility and offer the possibility to partially work from home, depending on the tasks.

Your tasks

• Perform all functions associated with process-, cleaning- and shipping validation (definition of validation strategy, planning, writing of plans/ protocols, execution support, evaluation of data and writing reports)
• Author and lead process risk analysis and define process control strategy
• Represent as Validation Subject Matter Expert (SME) on global project teams and validation councils
• Represent as Validation SME on internal teams (e.g. investigation and project teams)
• Author and support of deviations/ investigations and change controls in manufacturing
• Make recommendations for process changes and sponsor these to the larger process team, lead the implementation of the respective change controls
• Perform process monitoring (control charts) and statistical process analysis including authoring of continued process verification reports (CPV)
• Provide 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 receiving or sending process SME
• Actively drive Operational Excellence and Environmental Health and Safety improvements

About you:

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

We provide an opportunity to be a part of an international company that boasts exceptional technology and a determined team. Join our dedicated and agile MSAT team if you share our enthusiasm and have a desire to create an impact. You can expect a vibrant and adaptable work environment that supports the growth of your personal and technical skills. Additionally, we offer an extensive benefits package and a competitive compensation package.

Are you ready to join us in our mission?

If this sounds like the next step in your career, we would love to hear from you. Simply click the "APPLY" button on the right side of the page and you will be redirected to our application form. We are conducting interviews on an ongoing basis and encourage you to apply as soon as possible.

We look forward to receiving your CV, including your motivation for applying for this particular position. A cover letter is optional.

Applications submitted via email will not be considered.

We kindly request that headhunters or recuitment agencies refrain from contacting us regarding this position.

Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera and typhoid. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values - our Bavarian Nordic DNA, as we like to call it - are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! 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.
www.bavarian-nordic.com

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