CSV Engineer
Quality
Information
As a Computer System Validation (CSV) engineer you are:
- Assuring that all CSV related regulatory requirements are fulfilled during the complete life cycle (concept, project, operational and retirement phase) for computerized systems.
- Assuring proper CSV quality oversight and CSV quality management for IT systems related to CAR-T activities.
- Review and approve CSV documents (such as SOPs, user requirements, impact/risks analysis’s, validation plans, tests, etc…) in order to maintain compliance to regulations, guidelines, policies and standards.
- Be part of engineering teams and interact with other groups for the introduction of new systems and processes.
- Give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects. Be a member of cross-functional teams to realize cross-departmental objectives
- Address and follow-up of deviations occurred during execution of qualification/validation activities.
- Evaluate the incidents related to CS and propose corrective actions if necessary. Identify possible impact on the product quality and pass the incident to QA focus if this is the case.
- Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP,…), MAP, etc.
As CSV engineer you have
- (basic) knowledge of cGMP’s, GAMP’s, SW development and testing processes, Quality auditing, Software quality metrics,
- Capacity to ‘translate’ technical information into information that can be understood at every level of the organization
- A master's degree (preferably in engineering) with a strong interest (or experience) in computer systems.
- You speak English and Dutch and/or French
