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 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.
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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