Engineer Compliance CSV & DI (m/w/d)

In this role, you are responsible for the validation and qualification of computer systems and equipment in the regulated GMP environment, including the creation of documentation and the performance of tests. You ensure the adherence to quality standards and regulatory requirements and accompany audits and inspections.

Requirements

• Creation or revision of validation documents for computer systems in the GMP environment (e.g. validation plans, requirement specifications, risk analyses)
• Accompaniment or performance of tests and documentation of test results
• Initiation, processing, and follow-up of deviations, changes, and CAPAs incl. associated documentation (e.g. risk analyses, plan and report documents, SOPs)
• Support in the implementation and monitoring of Data Integrity requirements
• Monitoring the adherence to quality standards and regulatory requirements in the area of computer system validation
• Preparation and performance of training and participation in audits

Benefits

• Flexible working hours
• Individual holiday account
• Company bicycle
• Job ticket
• Deutschland ticket
• Employer-financed old-age provision
• Childcare
• Digital learning
• Programs for performance and talent development
• Leadership development
• Further training
• Access to LinkedIn Learning