Secondment via YER, Projectsourcing via YER
(Petro)Chemical, Energy, Gas, Water, Engineering
About this vacancy
We are looking for a Validation Engineer in Rijswijk. Your interest and experience is in technology, and you have Technical degree or equivalent with at least 5 year experience with focus on the life-science industry and a proven track record within Validation.
- Ability to establish a quality culture within the life-science team. This means that each member knows what they need to do on a particular project,
- Work with project teams to develop, for a given solution, best practices for design and code review, implementation and testing. Establish templates.
- Review (and at times help to prepare) project Quality Plans, and other quality relevant documents, and ensure good communication to project team.
- Develop project document control procedures, train the team and enforce in their use.
- Assist in Project management reporting of quality records/statistics
- Provide compliance and risk management guidance for projects to ensure consistency with compliance standards and the adherence of deliverables. Assist in developing project strategies to mitigate this risk.
- Ensure team is focused on User Requirements, co-ordinate project traceability and assist in reviewing project documentation (FS, CS, DS, test specifications).
- Develop configuration and change management strategy with lead engineer, and enforce its use.
- Develop Overall Test Strategy with Lead Engineer. Perform training at the start of test phases, to ensure testers (including customers) understand their responsibilities. Validate executed test documents
- Work with European management and PMO team to develop the life-science Quality Management System (QMS) which includes procedures, templates, tools and good practices.
- Perform internal audits on life-science projects to ensure quality standards are being met.
- Feedback internal audit actions to relevant Quality Managers (Europe and India) and PMO team
- Work with manager to resolve individual project and company quality issues
- Perform quality training to engineers and managers on Project Quality.
A multinational in Rijswijk.
- Salary in line with market
- Good secondary employment conditions
- Technical degree or equivalent with at least 5 year experience with focus on the life-science industry and a proven track record.
- Trained in ISO 9001 with auditor training and relevant experience
- Ability to influence the culture of a project team or department to adopt and maintain good quality standards.
- Experience in Quality Management and Quality Systems development.
- Proven experience and personal credibility in front of customers and colleagues is essential.
- Have good eye for detail and able to work accurately.
- Proactive and able to work effectively within a remote team.
- Excellent verbal and written communication skills.