Senior Computer System Validation Engineer (f/m/d)
We are looking to strengthen the Engineering Team in Bern with a Senior Computer System Validation Engineer. This role is a parental cover for 12 months. The team comprises more than 30 employees, operates in both German and English, and has a strong focus on continuous development.
Responsibilities
Review and approve CSV and OT‑related system lifecycle design documentation, including user requirements, functional and design specifications, data flow diagrams, commissioning and qualification protocols.
Perform cycle‑driven tasks such as Computerized System Periodic Review, Data Integrity Assessment, and Risk/Gap assessments with corresponding mitigation activities.
Commission and qualify software, spreadsheets and computerized equipment.
Investigate deviations, manage change control and CAPA activities; lead projects and site changes involving CSV and risk management.
Act as a subject‑matter expert for CSV topics, providing customer focus and supporting engineering, R&D, quality, manufacturing sciences, and technology teams.
Educational Background & Professional Expertise
BS/MSc in IT, Computer Science or equivalent with a strong track record in the biotech industry.
Minimum of 5 years of experience in CSV‑related field, with project‑management experience.
Languages: English (oral and written); German is a plus.
Expected Technical Competencies
Creation and execution of CSV deliverable packages (UR, SFDS, FDSHDS, HDS), commissioning and qualification protocols, data flow diagrams, periodic review reports, data integrity assessment reports, and risk/GAP assessment reports.
System validation: commissioning and qualification of software, spreadsheets and computerized systems.
Project management: lead and manage CSV and OT projects, coordinate with stakeholders, and adhere to timelines and budgets.
Regulatory knowledge: comprehensive understanding of GMP, GMP‑FDA, GAMP5, and other relevant regulatory guidelines.
Audit participation experience.
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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