As an experienced computer system validation engineer, you will support the implementation of software systems that are used in laboratory and production environments within the pharma industry. It will be your mission to guarantee the quality of these software systems. Within software validation there is a very wide range of possibilities. CSV projects can range from simple Excel sheets, medical devices, websites and HPLC software to complex systems that are used across multiple departments, throughout the site or even internationally: MES, LIMS, SAP, etc.
- You will be responsible for independently setting up and documenting a risk-based validation strategy
- Together with the business units concerned, you will draw up requirements and test protocols
- You will report results according to internal procedures and predefined templates
- You will assist the customer with regard to compliance with regulations such as Cfr21 Part 11/Annex 11
- You will be in close contact with different stakeholders and understand the interests of Quality Assurance, IT and the business
- You will be jointly responsible for determining the impact of changes and drawing up deviations
- You will help draw up and adapt work instructions and SOPs