Validation Engineer in MSAT

For us, it is all about improving and saving lives

In Bern, we're not just expanding-we're reaching a major milestone by launching a new production site and introducing innovative ways of working. This is what being a Persistent Pioneer in our BN DNA is all about-bringing a pioneering spirit to everything we do. Whether you're an experienced professional, transitioning from academia, or coming from a related industry, you'll have the unique opportunity to influence how we work and grow.

We are looking to strengthen the MSAT Validation Team with a

Validation Engineer in MSAT (f/m/d)

Position Summary

The role within the Manufacturing, Science and Technology team (MSAT) is responsible for developing a core competency in process-, cleaning- and shipping validation for biotechnological products through Process Performance Qualification (PPQ) campaigns, and commercial production, as well as identifying and leading technical investigations and providing technical advisement to Manufacturing Support Engineers.

This position incorporates continued process verification on commercial products and supporting technical problem-solving. This role may have other validation responsibilities as assigned but will primarily be in charge of process validation planning, validation execution support, retrieving process data, analyzing the data, looking for positive and adverse trends, correlating the findings, solving issues as noted by the data analysis for process improvement/ refinement, and creating written reports about the exercise.

You will be part of the MSAT Validation Team, who 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.

What you can expect

• 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, critical process parameter and critical quality attributes identification and define process control strategy
• Provide data, analyses, write-ups, reviews, and other input to annual Product Quality Reviews (PQR)
• Perform process monitoring (control charts) and statistical process analysis including authoring of continued process verification reports (CPV)
• 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)
• Participate in internal, customer and regulatory inspections
• Author and support of deviations/ investigations and change controls in manufacturing
• Make recommendations for process changes and sponsor these to the larger process team and lead the implementation of the respective change controls
• Support Technology Transfer projects as receiving or sending process SME
• Actively drive Operational Excellence and Environmental Health and Safety improvements

Your skills and qualifications

• Bachelor's degree or higher in Life Sciences, Graduates are very welcome
• 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 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 motivated CV, where you briefly explain your motivation for applying for this particular position. A cover letter is optional.

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, typhoid, and Ebola. 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.

www.bavarian-nordic.com
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