CSV Engineer
As a CSV Engineer Biologics (m/f/d) you will be responsible for the generation and execution of the validation of the computerized systems on process engineering equipment and facilities, including MES. You are responsible to follow the planning and implementation of CSV activities resulting from projects and plant adaptations during the system life cycle of the plants, as well as make a contribution to the ongoing optimization of processes, facilities and internal procedures.
Key responsibilities:
* Preparation of commissioning and validation documents for new systems, as well as the supervision of conversion, expansion and new construction projects. This is broken down into CSV activities on new construction projects for critical systems and SLC support for all systems after going live
* Supervision of deviations, changes (GEP and GMP), and CAPAs
* Coordination of CSV executions with internal groups, as well as external service providers and suppliers
* Responsible for the presentation of CSV documents during audits and inspections
* Scheduling and reporting of CSV activities
* Following the alignment of the CSV strategy with the QA CSV for all Biologics scope
* Contribution in the review and amelioration of all CSV documents
Key requirements:
Required: minimum 7 years in CSV in Biotech or Pharma (not Medical Devices CSV experience
* Bachelor / Master / Diploma from a technical school (HF) / university of applied sciences (FH) or university in a technical field
* Significant experience in a regulated environment with regard to Computerized System Validation (CSV)
* Good knowledge of Microsoft Office and Delta-V is required
* Knowledge of KNEAT, COMOS (plant engineering software solution), DMS, TrackWise and SAP is an advantage
* Fluent in English, German language skills are advantageous
