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About the Role
In this role, you will be solely responsible for all CSV topics at the site. The site is highly digitized, and the position is characterized primarily by extensive project and interface work, especially with IT and QA.
Responsibilities
- Qualification and validation of computer-aided systems and associated IT infrastructure in a GMP environment
- Creation and maintenance of relevant specifications, SOPs, and validation documents
- Execution of GMP, criticality, and risk assessments
- Processing of deviations, changes, and regular system reviews, including audit trail checks
- Planning, execution, and documentation of validation activities such as URS, IQ/OQ/PQ, and final reports
- Support for system introductions and changes in collaboration with IT and business units
- Support with audits, supplier evaluations, and training on CSV and compliance topics
Requirements
- Experience with Computer System Validation in the pharmaceutical or comparable GxP-regulated environment
- Good knowledge of regulatory requirements for computer-aided systems
- Practical experience in creating and reviewing validation and qualification documents
- Experience with systems such as ERP, MES, LIMS, eQMS, or similar applications
- Structured, analytical approach to work, and good communication skills for cross-departmental collaboration
- Fluent German and English skills
Benefits
- 37.5-hour week with time tracking and overtime reduction
- Unionized employment with holiday and Christmas bonus
- Extensive work-life balance (flexible hours, mobile working, overtime reduction, etc.)
- Company pension plan, accident insurance, comprehensive health offerings
- In-house Academy with good development opportunities
- Corporate Benefits, fitness offers, meal subsidies (lunch, fruit/muesli, various drinks, etc.)
- Challenging and varied field of activity
- Familiar and friendly atmosphere
- Various events and celebrations
Equal Opportunity
- For the sake of better readability, the simultaneous use of male, female, and diverse (m/f/d) language forms is omitted. All personal designations apply equally to all genders.