Description
Our client, a global pharmaceutical organisation, is looking for a Equipment Validation Engineer, who specialises in topics such as project management, validation, process management and equipment technology.RESPONSIBILITIES
- Demonstrates in-depth knowledge of validation requirements and procedures.
- Leads larger projects and provides expert consultation to management and site personnel as warranted.
- Mentors and guides other validation personnel on validation concepts and initiatives.
- Recommends tactical guidance for validation approaches in area(s) of expertise.
- Acts as a SME during audits (internal and external)
- Applies recognised company expertise in one or more areas of pharmaceutical equipment technology.
- Reviews and provides technical input for capital justifications.
- Works to minimise costs, and leads initiatives to standardise and harmonise equipment selection.
- Supports operations in running plants and/or utilities
- May direct and supervise colleagues and contractors
- Directs/conducts troubleshooting of complex processes, equipment and utility systems
- Develops and may supervise the development of complex technical procedures and documentation to meet regulatory requirements
- Leads/conducts process, equipment and resource performance studies to improve operating efficiency and reduce expenses
- Leads the commissioning and qualification of complex utilities and equipment.
- Leads/conducts the scope development and justification of new facility, equipment and/or technology projects
- Executes larger capital projects and ensures scope, timeline, cost, quality are achieved
- Provides input in the development of departmental budget acquisition and cost control plans
- Develops best engineering practices and standards
- Bachelor's degree in Engineering and eight years of experience, or Master's Degree and six to eight years of experience.
- Minimum 3 years of Equipment Validation Experience
- Fluent in English and Dutch
- Engineering related Degree strongly preferred or equivalent work experience required
- Builds and applies a wide-range of cross-functional and plant/site knowledge as well as subject-matter expertise. Evaluates new technologies and generates creative ideas that can be translated into measurable results
- Leverages technical expertise, combined with relationship building skills, to lead interdisciplinary teams focused on improving drug production and manufacturing strategies
- Consults to and influences internal and external manufacturing clients on technical issues and makes observable impact on raising global consistency and reproducibility in drug production standards.
- Understands and evaluates design of experiment options, conducts root-cause analysis and influences problem resolution, interprets data available to draw inferences and make recommendations
- Exhibits and applies engineering knowledge in area of responsibility and displays working knowledge of other engineering disciplines